Information Notice 1999-23, Safety Concerns Related to Repeated Control Unit Failures of the Nucletron Classic Model High-Dose-Rate Remote Afterloading Brachytherapy Devices: Difference between revisions

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{{#Wiki_filter:UNITED STATES NUCLEAR REGULATORY
{{#Wiki_filter:UNITED STATES


COMMISSION
NUCLEAR    REGULATORY      COMMISSION


===OFFICE OF NUCLEAR MATERIAL SAFETY AND SAFEGUARDS===
OFFICE OF NUCLEAR MATERIAL SAFETY AND SAFEGUARDS
WASHINGTON, D.C. 20555-0001 July 6, 1999 NRC INFORMATION


NOTICE 99-23: SAFETY CONCERNS RELATED TO REPEATED CONTROL UNIT FAILURES OF THE NUCLETRON CLASSIC MODEL HIGH-DOSE-RATE
WASHINGTON, D.C. 20555-0001 July 6, 1999 NRC INFORMATION NOTICE 99-23:             SAFETY CONCERNS RELATED TO REPEATED


REMOTE AFTERLOADING
CONTROL UNIT FAILURES OF THE NUCLETRON


BRACHYTHERAPY
CLASSIC MODEL HIGH-DOSE-RATE REMOTE


DEVICES
AFTERLOADING BRACHYTHERAPY DEVICES


==Addressees==
==Addressees==
:
:
All U.S. Nuclear Regulatory
                                                                          authorized to use


Commission (NRC) medical licensees
All U.S. Nuclear Regulatory Commission (NRC) medical licensees


authorized
remote afterloaders.


to use brachytherapy
brachytherapy sources in Nucletron Classic Model high-dose-rate (HDR)
 
sources in Nucletron
 
Classic Model high-dose-rate (HDR) remote afterloaders.


==Purpose==
==Purpose==
: NRC is issuing this information
:
                                                                            unit failures with Nucletron


notice to alert you to ongoing control unit failures with Nucletron Classic Model HDR devices. You should review this information
NRC is issuing this information notice to alert you to ongoing control                     to your facilities


for applicability
for applicability


to your facilities
Classic Model HDR devices. You should review this information                              patient


and consider actions, as appropriate, to minimize the impact of such failures on patient treatments
failures   on


and personnel
and consider actions, as appropriate, to minimize the impact of such


exposures.
suggestions    contained    in this information notice


However, suggestions
treatments and personnel exposures. However, response is required.


contained
are not NRC requirements; therefore, no specific action nor written


in this information
==Description of Circumstances==
:
                                                                                    Classic Model HDR


notice are not NRC requirements;
By January 1996, NRC was aware of three incidents where the Nucletron
therefore, no specific action nor written response is required.Description


of Circumstances:
unit failures exposed a
By January 1996, NRC was aware of three incidents


where the Nucletron
control units failed (locked up) for unexplained reasons. These control


Classic Model HDR control units failed (locked up) for unexplained
Classic Model HDR.


reasons. These control unit failures exposed a deficiency
deficiency in the design of the door interlock circuitry for the Nucletron


in the design of the door interlock
and providing


circuitry
Nucletron issued a Safety Alert on March 4, 1996, describing this problem


for the Nucletron
This  safety    alert was also issued


Classic Model HDR.Nucletron
information on the proper operator response to such failures.                                 discussed


issued a Safety Alert on March 4, 1996, describing
10, 1996,   that


this problem and providing information
as an attachment to NRC Information Notice 96-21, issued on April


on the proper operator response to such failures.
these three reported


This safety alert was also issued as an attachment
both the door interlock problem and the control unit failures. Following


to NRC Information
field  modifications    to these devices to


Notice 96-21, issued on April 10, 1996, that discussed both the door interlock
failures of the control unit, Nucletron Corporation made


problem and the control unit failures.
unexplained      control unit


Following
correct the door interlock failure mechanism and to eliminate the


these three reported failures of the control unit, Nucletron
failures.


Corporation
four in 1998, and three


made field modifications
Following these modifications, two similar failures were reported in 1997, since the 1996 corrective


to these devices to correct the door interlock
to date in 1999. These additional nine control unit failures, reported


failure mechanism
However, no further


and to eliminate
action, indicate a ongoing problem with unexplained control unit failures.                  has continued


the unexplained
interlocks.    Nucletron


control unit failures.Following
problems have been reported with the operation of the door                                      cause of


these modifications, two similar failures were reported in 1997, four in 1998, and three to date in 1999. These additional
the  root


nine control unit failures, reported since the 1996 corrective
to investigate the ongoing control unit failures and now believes it has found


action, indicate a ongoing problem with unexplained
We understand that


control unit failures.
the failures and subsequently developed appropriate corrective measures.


However, no further problems have been reported with the operation
before


of the door interlocks.
the newly developed corrective measures are presently undergoing testing


Nucletron
implementation.


has continued to investigate
c


the ongoing control unit failures and now believes it has found the root cause of the failures and subsequently
0t      rn4-] dwotaqq-O2s                            q4o1o


developed
eas


appropriate
-o4 cW


corrective
'-I


measures.
IN 99-23 July 6, 1999 Discussion:
                                                                                      were reported. In


We understand
In all 12 reported control unit failures no patient or personnel overexposures


that the newly developed
when communications with the


corrective
each case the treatment unit continued to operate, as designed, unit continues the


measures are presently
control unit was lost. In this event, the microprocessor in the treatment


undergoing
the failure occurs, halting upon


testing before implementation.
preprogrammed treatment to the catheter being treated when


0t rn4-] dwotaqq-O2s
or during the last catheter in


q4o1o -o4 cW c eas
completion. If the failure occurs during a single catheter treatment              Otherwise, it will


'-I IN 99-23 July 6, 1999 Discussion:
a multi-catheter operation, then the treatment will proceed to completion.              catheters
In all 12 reported control unit failures no patient or personnel


overexposures
any  remaining


were reported.
terminate with completion of the catheter being treated, leaving                    on an inoperative


In each case the treatment
display


unit continued
untreated. Most users, however, when faced with a blank or frozen


to operate, as designed, when communications
Stop" button on the control


with the control unit was lost. In this event, the microprocessor
control unit, immediately abort the treatment, using the "Emergency


in the treatment
on the  Safety Alert procedures)
unit. The "Treatment Interrupt" button (called for in the 1" step


unit continues
Irrespective of the method


the preprogrammed
on the control unit is rendered inoperative by the control unit failure.


treatment
can subsequently be read from


to the catheter being treated when the failure occurs, halting upon completion.
of terminating the patient's treatment, the actual treatment data


If the failure occurs during a single catheter treatment
the treatment unit, using a handheld terminal device.


or during the last catheter in a multi-catheter
of a control unit failure and, at


operation, then the treatment
Most patients receive less than the prescribed dose in the event


will proceed to completion.
must be revised to reflect the


Otherwise, it will terminate
the discretion of the Authorized User, either the Written Directive


with completion
after repair or replacement of


of the catheter being treated, leaving any remaining
actual dose given or the remaining portion of the treatment given


catheters untreated.
unit failures has resulted in


Most users, however, when faced with a blank or frozen display on an inoperative
the defective control unit. To date, none of the reported control


control unit, immediately
the control unit removes the first


abort the treatment, using the "Emergency
overexposures or misadministrations. However, the failure of


Stop" button on the control unit. The "Treatment
of excessive radiation exposures


Interrupt" button (called for in the 1" step on the Safety Alert procedures)
layer of radiation safety protection. At this point, the avoidance
on the control unit is rendered inoperative


by the control unit failure. Irrespective
unit or operator


of the method of terminating
depends upon either the continued proper operation of the treatment


the patient's
intervention.


treatment, the actual treatment
and included a copy of the


data can subsequently
NRC previously issued Information Notice 96-21 on April 10, 1996, as an attachment. This Safety


be read from the treatment
Nucletron issued Safety Alert, addressing the control unit failures, the Control Unit stops


unit, using a handheld terminal device.Most patients receive less than the prescribed
Alert sets forth a series of four steps to be taken if, for any reason, should ensure that the treatment


dose in the event of a control unit failure and, at the discretion
updating the status of the treatment in progress. These steps


of the Authorized
enter the treatment room. You


User, either the Written Directive
is interrupted and the source retracted before licensee personnel


must be revised to reflect the actual dose given or the remaining
vendor, as contained in its


portion of the treatment
are encouraged to follow these recommendations from the device


given after repair or replacement
to these control unit failures


of the defective
Safety Alert of March 4, 1996. Any questions you may have related


control unit. To date, none of the reported control unit failures has resulted in overexposures
should be addressed to your


or misadministrations.
and related corrective actions, or to get a copy of the Safety Alert, Nucletron Corporation representative.


However, the failure of the control unit removes the first layer of radiation
IN 99-23 July 6, 1999 If you have any


safety protection.
This information notice requires no specific action nor written response.


At this point, the avoidance
technical contact listed below


of excessive
questions about the information in this notice, please contact the


radiation
or the appropriate regional office.


exposures depends upon either the continued
Donald A. Cool, Director


proper operation
Division of Industrial and


of the treatment
Medical Nuclear Safety


unit or operator intervention.
Office of Nuclear Material Safety


NRC previously
and Safeguards


issued Information
Contact: Robert L. Ayres, NMSS


Notice 96-21 on April 10, 1996, and included a copy of the Nucletron
(301) 415-5746 E-mail: rxal nrc.gov


issued Safety Alert, addressing
Attachments:
1. List of Recently Issued NMSS Information Notices


the control unit failures, as an attachment.
2. List of Recently Issued NRC Information Notices


This Safety Alert sets forth a series of four steps to be taken if, for any reason, the Control Unit stops updating the status of the treatment
ItWt4                  a,-TV


in progress.
K-'                                I


These steps should ensure that the treatment is interrupted
Attachment 1 IN 99-23 July 6, 1999 LIST OF RECENTLY ISSUED


and the source retracted
NMSS INFORMATION NOTICES


before licensee personnel
Information                                        Date of


enter the treatment
Subject                        Issuance    Issued to


room. You are encouraged
Notice No.


to follow these recommendations
10 CFR 34.43(a)(1): Effective          6/25/99    Industrial Radiography Licensees


from the device vendor, as contained
99-22 Date for Radiographer    Certification


in its Safety Alert of March 4, 1996. Any questions
and Plans for Enforcement Discretion


you may have related to these control unit failures and related corrective
6/25/99    All material and fuel cycle


actions, or to get a copy of the Safety Alert, should be addressed
99-20      Contingency Planning for the


to your Nucletron
Year 2000 Computer Problem                        licensees and certificate holders


Corporation
Update on NRC's Year 2000              6/14/99    All material and fuel cycle


representative.
99-18 Activities for Materials Licensees                licensees and certificate


IN 99-23 July 6, 1999 This information
and Fuel Cycle Licensees and                      holders


notice requires no specific action nor written response.
Certificate Holders


If you have any questions
Federal Bureau of Investigation's      5/28        All U.S. Nuclear Regulatory


about the information
99-16- Nuclear Site Security Program                      Commission fuel cycle, power


in this notice, please contact the technical
reactor, and non-power reactor


contact listed below or the appropriate
licensees


regional office.Donald A. Cool, Director Division of Industrial
Incident Involving the Use of         4/16199      All medical use licensees


and Medical Nuclear Safety Office of Nuclear Material Safety and Safeguards
99-11 Radioactive lodine-1 31 Problems Encountered When              3/24/99    All medical licensees authorized


Contact: Robert L. Ayres, NMSS (301) 415-5746 E-mail: rxal nrc.gov Attachments:
99-09                                                          to conduct high-dose-rate (HDR)
1. List of Recently Issued NMSS Information
            Manually Editing treatment Data


Notices 2. List of Recently Issued NRC Information
on the Nucletron Microselectron-                    remote after loading


Notices ItWt4 a,-TV
HDR (New) Model 105-999                            brachytherapy treatments


K-'I Attachment
1998 Enforcement Sanctions as        3/19/99      All U. S. Nuclear Regulatory


1 IN 99-23 July 6, 1999 LIST OF RECENTLY ISSUED NMSS INFORMATION
99-06                                                          Commission licensees


NOTICES Information
a Result of Deliberate Violations


Date of Notice No. Subject Issuance Issued to 99-22 10 CFR 34.43(a)(1):
of NRC Employee Protection
Effective


6/25/99 Industrial
Requirements


Radiography
Inadvertent Discharge of Carbon      3/8/99      All holders of licenses for nuclear


Licensees Date for Radiographer
99-05                                                          power, research, and test reactor, Dioxide Fire Protection System


===Certification===
and fuel cycle facilities
and Plans for Enforcement


Discretion
and Gas Migration


99-20 99-18 99-16-99-11 99-09 99-06 99-05 99-04 99-03 Contingency
Unplanned Radiation Exposures          3/8/99       All radiography licensees


Planning for the 6/25/99 Year 2000 Computer Problem Update on NRC's Year 2000 6/14/99 Activities
99-04 to Radiographers, Resulting From


for Materials
Failures to Follow Proper Radiation


Licensees and Fuel Cycle Licensees
Safety Procedures


and Certificate
Exothermic Reactions Involving        1/29/99      All operating uranium recovery


Holders Federal Bureau of Investigation's
99-03 Dried Uranium Oxide Powder                          facilities that produce oxide


5/28 Nuclear Site Security Program Incident Involving
(Yellowcake)                                      powder (U308) (yellowcake)


the Use of 4/16199 Radioactive
v>                                      Attachment 2 IN 99-23 July 6, 1999 LIST OF RECENTLY ISSUED


lodine-1 31 Problems Encountered
NRC INFORMATION NOTICES


When 3/24/99 Manually Editing treatment
Information                                              Date of


Data on the Nucletron
Subject                          Issuance Issued to


Microselectron- HDR (New) Model 105-999 1998 Enforcement
Notice No.


Sanctions
99-22            10 CFR 34.43(a)(1); Effective          7/6/99  Industrial Radiography Licensees


as 3/19/99 a Result of Deliberate
Date  for Radiographer  Certification


Violations
and Plans for Enforcement Discretion


of NRC Employee Protection
Recent Plant Events Caused            6/25/99  All holders of licenses for nuclear


===Requirements===
99-21                                                            power, test, and research reactors
Inadvertent


Discharge
By Human Performance Errors


of Carbon 3/8/99 Dioxide Fire Protection
6/25/99 All material and fuel cycle


System and Gas Migration Unplanned
99-20            Contingency Planning for the


Radiation
Year 200 Computer Problem                        licensees and certificate holders


Exposures
Rupture of the Shell Side of a        6/23/99  All holders of operating licenses


3/8/99 to Radiographers, Resulting
99-19                                                            or construction permits for nuclear


From Failures to Follow Proper Radiation Safety Procedures
Feedwater Heater at the Point


Exothermic
Beach Nuclear Plant                              power reactors


Reactions
Update on NRC's Year 2000            6/14/99  All material and fuel cycle


Involving
99-18                                                              licensees and certificate holders


1/29/99 Dried Uranium Oxide Powder (Yellowcake)
Activities for Materials Licensees
All material and fuel cycle licensees


and certificate
and Fuel Cycle Licensees and


holders All material and fuel cycle licensees
Certificate Holders


and certificate
Problems Associated with Post-Fire 6/3/99      All holders of OL for nuclear


holders All U.S. Nuclear Regulatory
99-17 Safe-Shutdown Circuit Analyses                  power reactors, except those who


Commission
have permanently ceased


fuel cycle, power reactor, and non-power
operations and have certified that


reactor licensees All medical use licensees All medical licensees
the fuel has been permanently


authorized
removed from the reactor


to conduct high-dose-rate (HDR)remote after loading brachytherapy
Federal Bureau of Investigation's      5/28    All U.S. Nuclear Regulatory


treatments
99-16- Nuclear Site Security Program                    Commission fuel cycle, power


===All U. S. Nuclear Regulatory===
reactor, and non-power reactor
Commission


licensees All holders of licenses for nuclear power, research, and test reactor, and fuel cycle facilities
licensees


All radiography
Misapplication of 10 CFR Part 71      5/27/99  All holders of operating licenses or


licensees All operating
99-15                                                            construction permits for nuclear


uranium recovery facilities
Transportation Shipping Cask


that produce oxide powder (U 3 0 8) (yellowcake)
Licensing Basis to 10 CFR Part 50                power reactors
v>Attachment


2 IN 99-23 July 6, 1999 LIST OF RECENTLY ISSUED NRC INFORMATION
Design Basis


NOTICES Information
OL = Operating License


Date of Notice No. Subject Issuance Issued to 99-22 10 CFR 34.43(a)(1);
CP = Construction Permit
Effective


7/6/99 Industrial
-1,-23
                                  <lI                                    >, 6, 1999 response. If you have any


Radiography
This information notice requires no specific action nor written


Licensees Date for Radiographer
the technical contact listed below


===Certification===
questions about the information in this notice, please contact
and Plans for Enforcement


Discretion
or the appropriate regional office.


99-21 99-20 99-19 99-18 99-17 99-16-99-15 Recent Plant Events Caused By Human Performance
(ORIG. SIGNED BY)
                                                  Donald A. Cool, Director


Errors Contingency
Division of Industrial and


Planning for the Year 200 Computer Problem Rupture of the Shell Side of a Feedwater
Medical Nuclear Safety


Heater at the Point Beach Nuclear Plant Update on NRC's Year 2000 Activities
Office of Nuclear Material Safety


for Materials
and Safeguards


Licensees and Fuel Cycle Licensees
Contact: Robert L. Ayres, NMSS


and Certificate
(301) 415-5746 E-mail: rxal nrc.gov


Holders 6/25/99 6/25/99 6/23/99 6/14/99 All holders of licenses for nuclear power, test, and research reactors All material and fuel cycle licensees
Attachments:
    1. List of Recently Issued NMSS Information Notices


and certificate
2. List of Recently Issued NRC Information Notices


holders All holders of operating
DOCUMENT NAME: A & G:%AYRES\IN99C-XX.WPD


licenses or construction
* See previous concurrence
 
permits for nuclear power reactors All material and fuel cycle licensees
 
and certificate
 
holders All holders of OL for nuclear power reactors, except those who have permanently


ceased operations
MSIB*        IN


and have certified
OFFICE              JMSIB    C    Editor*  I MSIB*            Ms                            N


that the fuel has been permanently
EKraus    FSturz          LCamper          DCool


removed from the reactor All U.S. Nuclear Regulatory
NAME            RAyres/liucy


Commission
6109 /99  6115/99          6/15/99          6/28/99 DATE            6/ 09 /99 n rn0PV


fuel cycle, power reactor, and non-power
A4~w^=rloEIf


reactor licensees All holders of operating
s


licenses or construction
O


permits for nuclear power reactors Problems Associated
AI aMen


with Post-Fire
r K~~~AMLREGO~    I %L  u


6/3/99 Safe-Shutdown
W


Circuit Analyses Federal Bureau of Investigation's
IN 99-XX


5/28 Nuclear Site Security Program Misapplication
AJ      June XX, 1999 This information notice requires no specific action nor written response. If you have any


of 10 CFR Part 71 Transportation
questions about the information in this notice, please contact the technical contact listed below


Shipping Cask Licensing
or the appropriate regional office.


Basis to 10 CFR Part 50 Design Basis 5/27/99 OL = Operating
Donald A. Cool, Director


License CP = Construction
Division of Industrial and


Permit
Medical Nuclear Safety


<lI-1,-23>, 6, 1999 This information
Office of Nuclear Material Safety


notice requires no specific action nor written response.
and Safeguards


If you have any questions
Contact: Robert L. Ayres, NMSS


about the information
(301) 415-5746 E-mail: rxal @nrc.gov                                /
    Attachments:
    1. List of Recently Issued NMSS Information Notices


in this notice, please contact the technical
2. List of Recently Issued NRC Information Notices A


contact listed below or the appropriate
''</
 
                          /
regional office.(ORIG. SIGNED BY)Donald A. Cool, Director Division of Industrial
    DOCUMENT NAME: A & G:\AYRES\IN99C-XX.WPD
 
and Medical Nuclear Safety Office of Nuclear Material Safety and Safeguards
 
Contact: Robert L. Ayres, NMSS (301) 415-5746 E-mail: rxal nrc.gov Attachments:
1. List of Recently Issued NMSS Information
 
Notices 2. List of Recently Issued NRC Information
 
Notices DOCUMENT NAME: A & G:%AYRES\IN99C-XX.WPD


* See previous concurrence
* See previous concurrence


OFFICE JMSIB C Editor* I MSIB* N Ms MSIB* I N NAME RAyres/liucy
OFFICE         MSIB      IC  Editor   I     MSIB*     I    lISIB        l    MSIB       IN
 
EKraus FSturz LCamper DCool DATE 6/ 09 /99 6109 /99 6115/99 6/15/99 6/28/99 s ^=rloEIf AI aMen n rn0PV A4~w O r K~~~AML REGO~ I u %L W
 
IN 99-XX AJ June XX, 1999 This information


notice requires no specific action nor written response.
NAME          RAyrestic      EKraus          FSturz          LCamper          DC_______
DATE          6/ 09 /99      6/09 /99        6/15/99          6/15/99          6/.t1/99 OFFICIAL RECORD COPY


If you have any questions
.z~ IN 99-XX


about the information
June xx, 1999 DOCUMENT NAME: A & G:\AYRES\IN99C-XX.WPD                                      tfqff      /
                                                                          &#xa3;fL411V5.--/0 :"//


in this notice, please contact the technical
* See orevious concurrence


contact listed below or the appropriate
OFFICE        MSIB    C        Editor    I MSIB      MSIB    N      MSIB        l NN/
NAME          RAyres/jcy      EKraus      FSturz    LCamper        DCooI


regional office.Donald A. Cool, Director Division of Industrial
,,
DATE        16/ 9 /99          6/ 09 /99  6/ IU< /99 6/ IS /99    16/    ,199 OFFICIAL RECORD COPY


and Medical Nuclear Safety Office of Nuclear Material Safety and Safeguards
I/
                                                                /'
                                                              ,
                                                      ,
                            Ii


Contact: Robert L. Ayres, NMSS (301) 415-5746 E-mail: rxal @nrc.gov /Attachments:
6 I~-                                   IN 99-XX
1. List of Recently Issued NMSS Information


Notices 2. List of Recently Issued NRC Information
L/   June xx, 1999 DOCUMENT NAME: A & G:\AYRES\1N99C-XX.WPD
 
Notices A''<//DOCUMENT NAME: A & G:\AYRES\IN99C-XX.WPD


* See previous concurrence
* See previous concurrence


OFFICE MSIB I C Editor I MSIB* I lISIB l MSIB I N NAME RAyrestic
OFFICE     _    SBIC          Eio*I   M~-             S9fIN      MI
 
EKraus FSturz LCamper DC_______DATE 6/ 09 /99 6/09 /99 6/15/99 6/15/99 6/.t1/99 OFFICIAL RECORD COPY
 
.z~ IN 99-XX June xx, 1999 DOCUMENT NAME: A & G:\AYRES\IN99C-XX.WPD
 
tfqff /&#xa3;fL411V5.
 
--/ 0 :"//* See orevious concurrence
 
OFFICE MSIB C Editor I MSIB MSIB N MSIB l NN /NAME RAyres/jcy
 
EKraus FSturz LCamper DCooI ,, DATE 16/ 9 /99 6/ 09 /99 6/ IU< /99 6/ IS /99 16/ ,199 OFFICIAL RECORD COPY I//', , Ii
 
6 I~-IN 99-XX L/ June xx, 1999 DOCUMENT NAME: A & G:\AYRES\1N99C-XX.WPD
 
* See previous concurrence


OFFICE _ SBIC Eio*I M~- S9fIN MI NAME RAyres/kicy
NAME         RAyres/kicy   EKraus            -          erCool D


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Latest revision as of 04:50, 24 November 2019

Safety Concerns Related to Repeated Control Unit Failures of the Nucletron Classic Model High-Dose-Rate Remote Afterloading Brachytherapy Devices
ML031040399
Person / Time
Site: Beaver Valley, Millstone, Hatch, Monticello, Calvert Cliffs, Dresden, Davis Besse, Peach Bottom, Browns Ferry, Salem, Oconee, Mcguire, Nine Mile Point, Palisades, Palo Verde, Perry, Indian Point, Fermi, Kewaunee, Catawba, Harris, Wolf Creek, Saint Lucie, Point Beach, Oyster Creek, Watts Bar, Hope Creek, Grand Gulf, Cooper, Sequoyah, Byron, Pilgrim, Arkansas Nuclear, Three Mile Island, Braidwood, Susquehanna, Summer, Prairie Island, Columbia, Seabrook, Brunswick, Surry, Limerick, North Anna, Turkey Point, River Bend, Vermont Yankee, Crystal River, Haddam Neck, Ginna, Diablo Canyon, Callaway, Vogtle, Waterford, Duane Arnold, Farley, Robinson, Clinton, South Texas, San Onofre, Cook, Comanche Peak, Yankee Rowe, Maine Yankee, Quad Cities, Humboldt Bay, La Crosse, Big Rock Point, Rancho Seco, Zion, Midland, Bellefonte, Fort Calhoun, FitzPatrick, McGuire, LaSalle, Fort Saint Vrain, Shoreham, Satsop, Trojan, Atlantic Nuclear Power Plant  Entergy icon.png
Issue date: 07/06/1999
From: Cool D
NRC/NMSS/IMNS
To:
References
IN-99-023, NUDOCS 9907010001
Download: ML031040399 (9)
v • d • e


UNITED STATES

NUCLEAR REGULATORY COMMISSION

OFFICE OF NUCLEAR MATERIAL SAFETY AND SAFEGUARDS

WASHINGTON, D.C. 20555-0001 July 6, 1999 NRC INFORMATION NOTICE 99-23: SAFETY CONCERNS RELATED TO REPEATED

CONTROL UNIT FAILURES OF THE NUCLETRON

CLASSIC MODEL HIGH-DOSE-RATE REMOTE

AFTERLOADING BRACHYTHERAPY DEVICES

Addressees

authorized to use

All U.S. Nuclear Regulatory Commission (NRC) medical licensees

remote afterloaders.

brachytherapy sources in Nucletron Classic Model high-dose-rate (HDR)

Purpose

unit failures with Nucletron

NRC is issuing this information notice to alert you to ongoing control to your facilities

for applicability

Classic Model HDR devices. You should review this information patient

failures on

and consider actions, as appropriate, to minimize the impact of such

suggestions contained in this information notice

treatments and personnel exposures. However, response is required.

are not NRC requirements; therefore, no specific action nor written

Description of Circumstances

Classic Model HDR

By January 1996, NRC was aware of three incidents where the Nucletron

unit failures exposed a

control units failed (locked up) for unexplained reasons. These control

Classic Model HDR.

deficiency in the design of the door interlock circuitry for the Nucletron

and providing

Nucletron issued a Safety Alert on March 4, 1996, describing this problem

This safety alert was also issued

information on the proper operator response to such failures. discussed

10, 1996, that

as an attachment to NRC Information Notice 96-21, issued on April

these three reported

both the door interlock problem and the control unit failures. Following

field modifications to these devices to

failures of the control unit, Nucletron Corporation made

unexplained control unit

correct the door interlock failure mechanism and to eliminate the

failures.

four in 1998, and three

Following these modifications, two similar failures were reported in 1997, since the 1996 corrective

to date in 1999. These additional nine control unit failures, reported

However, no further

action, indicate a ongoing problem with unexplained control unit failures. has continued

interlocks. Nucletron

problems have been reported with the operation of the door cause of

the root

to investigate the ongoing control unit failures and now believes it has found

We understand that

the failures and subsequently developed appropriate corrective measures.

before

the newly developed corrective measures are presently undergoing testing

implementation.

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eas

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IN 99-23 July 6, 1999 Discussion:

were reported. In

In all 12 reported control unit failures no patient or personnel overexposures

when communications with the

each case the treatment unit continued to operate, as designed, unit continues the

control unit was lost. In this event, the microprocessor in the treatment

the failure occurs, halting upon

preprogrammed treatment to the catheter being treated when

or during the last catheter in

completion. If the failure occurs during a single catheter treatment Otherwise, it will

a multi-catheter operation, then the treatment will proceed to completion. catheters

any remaining

terminate with completion of the catheter being treated, leaving on an inoperative

display

untreated. Most users, however, when faced with a blank or frozen

Stop" button on the control

control unit, immediately abort the treatment, using the "Emergency

on the Safety Alert procedures)

unit. The "Treatment Interrupt" button (called for in the 1" step

Irrespective of the method

on the control unit is rendered inoperative by the control unit failure.

can subsequently be read from

of terminating the patient's treatment, the actual treatment data

the treatment unit, using a handheld terminal device.

of a control unit failure and, at

Most patients receive less than the prescribed dose in the event

must be revised to reflect the

the discretion of the Authorized User, either the Written Directive

after repair or replacement of

actual dose given or the remaining portion of the treatment given

unit failures has resulted in

the defective control unit. To date, none of the reported control

the control unit removes the first

overexposures or misadministrations. However, the failure of

of excessive radiation exposures

layer of radiation safety protection. At this point, the avoidance

unit or operator

depends upon either the continued proper operation of the treatment

intervention.

and included a copy of the

NRC previously issued Information Notice 96-21 on April 10, 1996, as an attachment. This Safety

Nucletron issued Safety Alert, addressing the control unit failures, the Control Unit stops

Alert sets forth a series of four steps to be taken if, for any reason, should ensure that the treatment

updating the status of the treatment in progress. These steps

enter the treatment room. You

is interrupted and the source retracted before licensee personnel

vendor, as contained in its

are encouraged to follow these recommendations from the device

to these control unit failures

Safety Alert of March 4, 1996. Any questions you may have related

should be addressed to your

and related corrective actions, or to get a copy of the Safety Alert, Nucletron Corporation representative.

IN 99-23 July 6, 1999 If you have any

This information notice requires no specific action nor written response.

technical contact listed below

questions about the information in this notice, please contact the

or the appropriate regional office.

Donald A. Cool, Director

Division of Industrial and

Medical Nuclear Safety

Office of Nuclear Material Safety

and Safeguards

Contact: Robert L. Ayres, NMSS

(301) 415-5746 E-mail: rxal nrc.gov

Attachments:

1. List of Recently Issued NMSS Information Notices

2. List of Recently Issued NRC Information Notices

ItWt4 a,-TV

K-' I

Attachment 1 IN 99-23 July 6, 1999 LIST OF RECENTLY ISSUED

NMSS INFORMATION NOTICES

Information Date of

Subject Issuance Issued to

Notice No.

10 CFR 34.43(a)(1): Effective 6/25/99 Industrial Radiography Licensees

99-22 Date for Radiographer Certification

and Plans for Enforcement Discretion

6/25/99 All material and fuel cycle

99-20 Contingency Planning for the

Year 2000 Computer Problem licensees and certificate holders

Update on NRC's Year 2000 6/14/99 All material and fuel cycle

99-18 Activities for Materials Licensees licensees and certificate

and Fuel Cycle Licensees and holders

Certificate Holders

Federal Bureau of Investigation's 5/28 All U.S. Nuclear Regulatory

99-16- Nuclear Site Security Program Commission fuel cycle, power

reactor, and non-power reactor

licensees

Incident Involving the Use of 4/16199 All medical use licensees

99-11 Radioactive lodine-1 31 Problems Encountered When 3/24/99 All medical licensees authorized

99-09 to conduct high-dose-rate (HDR)

Manually Editing treatment Data

on the Nucletron Microselectron- remote after loading

HDR (New) Model 105-999 brachytherapy treatments

1998 Enforcement Sanctions as 3/19/99 All U. S. Nuclear Regulatory

99-06 Commission licensees

a Result of Deliberate Violations

of NRC Employee Protection

Requirements

Inadvertent Discharge of Carbon 3/8/99 All holders of licenses for nuclear

99-05 power, research, and test reactor, Dioxide Fire Protection System

and fuel cycle facilities

and Gas Migration

Unplanned Radiation Exposures 3/8/99 All radiography licensees

99-04 to Radiographers, Resulting From

Failures to Follow Proper Radiation

Safety Procedures

Exothermic Reactions Involving 1/29/99 All operating uranium recovery

99-03 Dried Uranium Oxide Powder facilities that produce oxide

(Yellowcake) powder (U308) (yellowcake)

v> Attachment 2 IN 99-23 July 6, 1999 LIST OF RECENTLY ISSUED

NRC INFORMATION NOTICES

Information Date of

Subject Issuance Issued to

Notice No.

99-22 10 CFR 34.43(a)(1); Effective 7/6/99 Industrial Radiography Licensees

Date for Radiographer Certification

and Plans for Enforcement Discretion

Recent Plant Events Caused 6/25/99 All holders of licenses for nuclear

99-21 power, test, and research reactors

By Human Performance Errors

6/25/99 All material and fuel cycle

99-20 Contingency Planning for the

Year 200 Computer Problem licensees and certificate holders

Rupture of the Shell Side of a 6/23/99 All holders of operating licenses

99-19 or construction permits for nuclear

Feedwater Heater at the Point

Beach Nuclear Plant power reactors

Update on NRC's Year 2000 6/14/99 All material and fuel cycle

99-18 licensees and certificate holders

Activities for Materials Licensees

and Fuel Cycle Licensees and

Certificate Holders

Problems Associated with Post-Fire 6/3/99 All holders of OL for nuclear

99-17 Safe-Shutdown Circuit Analyses power reactors, except those who

have permanently ceased

operations and have certified that

the fuel has been permanently

removed from the reactor

Federal Bureau of Investigation's 5/28 All U.S. Nuclear Regulatory

99-16- Nuclear Site Security Program Commission fuel cycle, power

reactor, and non-power reactor

licensees

Misapplication of 10 CFR Part 71 5/27/99 All holders of operating licenses or

99-15 construction permits for nuclear

Transportation Shipping Cask

Licensing Basis to 10 CFR Part 50 power reactors

Design Basis

OL = Operating License

CP = Construction Permit

-1,-23

  • , 6, 1999 response. If you have any This information notice requires no specific action nor written the technical contact listed below questions about the information in this notice, please contact or the appropriate regional office. (ORIG. SIGNED BY) Donald A. Cool, Director Division of Industrial and Medical Nuclear Safety Office of Nuclear Material Safety and Safeguards Contact: Robert L. Ayres, NMSS (301) 415-5746 E-mail: rxal nrc.gov Attachments: 1. List of Recently Issued NMSS Information Notices 2. List of Recently Issued NRC Information Notices DOCUMENT NAME: A & G:%AYRES\IN99C-XX.WPD
    • See previous concurrence
    MSIB* IN OFFICE JMSIB C Editor* I MSIB* Ms N EKraus FSturz LCamper DCool NAME RAyres/liucy 6109 /99 6115/99 6/15/99 6/28/99 DATE 6/ 09 /99 n rn0PV A4~w^=rloEIf s O AI aMen r K~~~AMLREGO~ I %L u W IN 99-XX AJ June XX, 1999 This information notice requires no specific action nor written response. If you have any questions about the information in this notice, please contact the technical contact listed below or the appropriate regional office. Donald A. Cool, Director Division of Industrial and Medical Nuclear Safety Office of Nuclear Material Safety and Safeguards Contact: Robert L. Ayres, NMSS (301) 415-5746 E-mail: rxal @nrc.gov / Attachments: 1. List of Recently Issued NMSS Information Notices 2. List of Recently Issued NRC Information Notices A </ / DOCUMENT NAME: A & G:\AYRES\IN99C-XX.WPD
    • See previous concurrence
    OFFICE MSIB IC Editor I MSIB* I lISIB l MSIB IN NAME RAyrestic EKraus FSturz LCamper DC_______ DATE 6/ 09 /99 6/09 /99 6/15/99 6/15/99 6/.t1/99 OFFICIAL RECORD COPY .z~ IN 99-XX June xx, 1999 DOCUMENT NAME: A & G:\AYRES\IN99C-XX.WPD tfqff / £fL411V5.--/0 :"//
    • See orevious concurrence
    OFFICE MSIB C Editor I MSIB MSIB N MSIB l NN/ NAME RAyres/jcy EKraus FSturz LCamper DCooI ,, DATE 16/ 9 /99 6/ 09 /99 6/ IU< /99 6/ IS /99 16/ ,199 OFFICIAL RECORD COPY I/ /' , , Ii 6 I~- IN 99-XX L/ June xx, 1999 DOCUMENT NAME: A & G:\AYRES\1N99C-XX.WPD
    • See previous concurrence
    OFFICE _ SBIC Eio*I M~- S9fIN MI NAME RAyres/kicy EKraus - erCool D DATE 16/ 09 /99 6/09 /99 Is__ 199 6/ ____99__ 6/ /99 OFFICIAL RECORD COPY


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