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

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
Issue date:	07/06/1999
From:	Cool D NRC/NMSS/IMNS
To:
References
IN-99-023, NUDOCS 9907010001
Download: ML031040399 (9)

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.

c

0t rn4-] dwotaqq-O2s q4o1o

eas

-o4 cW

'-I

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