Safety Defect in Gammamed 12i Bronchial Catheter Clamping AdaptersML031060156 |
Person / Time |
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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 |
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Issue date: |
10/30/1995 |
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From: |
Cool D NRC/NMSS/IMNS |
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To: |
|
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References |
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IN-95-050, NUDOCS 9510240405 |
Download: ML031060156 (12) |
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Similar Documents at 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 |
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Mclaughlin on NRC, Regarding NRC Information Notice 2006-13: Groundwater Contamination 2020-09-03 The following query condition could not be considered due to this wiki's restrictions on query size or depth: <code> [[:Beaver Valley]] OR [[:Millstone]] OR [[:Hatch]] OR [[:Monticello]] OR [[:Calvert Cliffs]] OR [[:Dresden]] OR [[:Davis Besse]] OR [[:Peach Bottom]] OR [[:Browns Ferry]] OR [[:Salem]] OR [[:Oconee]] OR [[:Mcguire]] OR [[:Nine Mile Point]] OR [[:Palisades]] OR [[:Palo Verde]] OR [[:Perry]] OR [[:Indian Point]] OR [[:Fermi]] OR [[:Kewaunee]] OR [[:Catawba]] OR [[:Harris]] OR [[:Wolf Creek]] OR [[:Saint Lucie]] OR [[:Point Beach]] OR [[:Oyster Creek]] OR [[:Watts Bar]] OR [[:Hope Creek]] OR [[:Grand Gulf]] OR [[:Cooper]] OR [[:Sequoyah]] OR [[:Byron]] OR [[:Pilgrim]] OR [[:Arkansas Nuclear]] OR [[:Three Mile Island]] OR [[:Braidwood]] OR [[:Susquehanna]] OR [[:Summer]] OR [[:Prairie Island]] OR [[:Columbia]] OR [[:Seabrook]] OR [[:Brunswick]] OR [[:Surry]] OR [[:Limerick]] OR [[:North Anna]] OR [[:Turkey Point]] OR [[:River Bend]] OR [[:Vermont Yankee]] OR [[:Crystal River]] OR [[:Haddam Neck]] OR [[:Ginna]] OR [[:Diablo Canyon]] OR [[:Callaway]] OR [[:Vogtle]] OR [[:Waterford]] OR [[:Duane Arnold]] OR [[:Farley]] OR [[:Robinson]] OR [[:Clinton]] OR [[:South Texas]] OR [[:San Onofre]] OR [[:Cook]] OR [[:Comanche Peak]] OR [[:Yankee Rowe]] OR [[:Maine Yankee]] OR [[:Quad Cities]] OR [[:Humboldt Bay]] OR [[:La Crosse]] OR [[:Big Rock Point]] OR [[:Rancho Seco]] OR [[:Zion]] OR [[:Midland]] OR [[:Bellefonte]] OR [[:Fort Calhoun]] OR [[:FitzPatrick]] OR [[:McGuire]] OR [[:LaSalle]] OR [[:Fort Saint Vrain]] OR [[:Shoreham]] OR [[:Satsop]] OR [[:Trojan]] OR [[:Atlantic Nuclear Power Plant]] </code>.
[Table view]The following query condition could not be considered due to this wiki's restrictions on query size or depth: <code> [[:Beaver Valley]] OR [[:Millstone]] OR [[:Hatch]] OR [[:Monticello]] OR [[:Calvert Cliffs]] OR [[:Dresden]] OR [[:Davis Besse]] OR [[:Peach Bottom]] OR [[:Browns Ferry]] OR [[:Salem]] OR [[:Oconee]] OR [[:Mcguire]] OR [[:Nine Mile Point]] OR [[:Palisades]] OR [[:Palo Verde]] OR [[:Perry]] OR [[:Indian Point]] OR [[:Fermi]] OR [[:Kewaunee]] OR [[:Catawba]] OR [[:Harris]] OR [[:Wolf Creek]] OR [[:Saint Lucie]] OR [[:Point Beach]] OR [[:Oyster Creek]] OR [[:Watts Bar]] OR [[:Hope Creek]] OR [[:Grand Gulf]] OR [[:Cooper]] OR [[:Sequoyah]] OR [[:Byron]] OR [[:Pilgrim]] OR [[:Arkansas Nuclear]] OR [[:Three Mile Island]] OR [[:Braidwood]] OR [[:Susquehanna]] OR [[:Summer]] OR [[:Prairie Island]] OR [[:Columbia]] OR [[:Seabrook]] OR [[:Brunswick]] OR [[:Surry]] OR [[:Limerick]] OR [[:North Anna]] OR [[:Turkey Point]] OR [[:River Bend]] OR [[:Vermont Yankee]] OR [[:Crystal River]] OR [[:Haddam Neck]] OR [[:Ginna]] OR [[:Diablo Canyon]] OR [[:Callaway]] OR [[:Vogtle]] OR [[:Waterford]] OR [[:Duane Arnold]] OR [[:Farley]] OR [[:Robinson]] OR [[:Clinton]] OR [[:South Texas]] OR [[:San Onofre]] OR [[:Cook]] OR [[:Comanche Peak]] OR [[:Yankee Rowe]] OR [[:Maine Yankee]] OR [[:Quad Cities]] OR [[:Humboldt Bay]] OR [[:La Crosse]] OR [[:Big Rock Point]] OR [[:Rancho Seco]] OR [[:Zion]] OR [[:Midland]] OR [[:Bellefonte]] OR [[:Fort Calhoun]] OR [[:FitzPatrick]] OR [[:McGuire]] OR [[:LaSalle]] OR [[:Fort Saint Vrain]] OR [[:Shoreham]] OR [[:Satsop]] OR [[:Trojan]] OR [[:Atlantic Nuclear Power Plant]] </code>. |
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UNITED STATES
NUCLEAR REGULATORY COMMISSION
OFFICE OF NUCLEAR MATERIAL SAFETY AND SAFEGUARDS
WASHINGTON, D.C. 20555-0001 October 30, 1995 NRC INFORMATION NOTICE 95-50:. SAFETY DEFECT IN GAMMAMED 12i BRONCHIAL
CATHETER CLAMPING ADAPTERS
Addressees
All High Dose Rate Afterloader (HDR) licensees.
Purpose
The U.S. Nuclear Regulatory Commission is issuing this information notice to
alert addressees to the manufacturer's recommendation to discontinue use of
GammaMed 12i 1.8-millimeter(mm) bronchial catheter adapters. It is expected
that recipients will review the information for applicability to their
facilities and consider actions, as appropriate, to avoid similar problems.
However, suggestions contained in this information notice are not new NRC
requirements; therefore, no specific action nor written response is required.
DescriDtion of Circumstances
During a bronchial treatment, on November 16, 1994, using a GammaMed 12i HDR,
the bronchial catheter pulled out of the catheter clamping adapter. This
resulted in the clamping adapter clamping on the source wire, producing an
abnormally high amount of friction during subsequent source movement. On
detection of this interference to source movement, the device initiated an
emergency retract, thus terminating the patient treatment. During this
emergency retract, the source became stuck in the clamping adapter, necessitating prompt emergency response, by the Radiation Oncology staff, to
evacuate the patient from the high radiation area. The staff's prompt action, limited the excess whole body exposure to the patient to less than
0.4 millisieverts (40 millirem). However, the HDR source and drive mechanisms
were damaged and required replacement.
On July 13, 1995, a similar incident occurred while vendor representatives
were performing the acceptance testing on a new GammaMed 12i. Again, the
source became stuck in the bronchial catheter clamping adapter after the
catheter had pulled loose from the adapter. In freeing the stuck source, the
vendor's Radiation Safety Officer received an estimated extremity dose of
26 centigray (rads). No patient was involved in this Incident.
Discussion
After the first incident in November 1994, Frank Barker Associates, Inc.,
provided all its GammaMed 12i customers with instructions for proper use of
the GammaMed 12i, 1.8-mm bronchial catheter and associated clamping adapter.
This notification (Attachment 1) was provided in the form of a BARKER+ TECH-
TIP dated November 22, 1994.
9 510240405 i
PP& qPS&o 9S Y4 got
IN 95-50
October 30, 1995 After the second incident in July 1995, Frank Barker Associates, Inc., issued
two more notifications, to its customers on the use of the 1.8-mm bronchial
catheter clamping adapters, Product Number 931-012. The first of these
(Attachment 2) was another BARKER+ TECH-TIP, dated July 18, 1995, which
advised customers to avoid the Wend testm mode of operation with the white
1.8-mm bronchial catheter, as this mode will stretch the catheter and possibly
push the catheter out of the clamping adapter. This TECH-TIP goes on to
describe the sticking of the source, in the clamping adapter, should the
catheter be pushed out of the adapter.
Frank Barker Associates, Inc. also held discussions with the NRC, regarding
radiation safety issues associated with the failure of the GammaMed 12i
devices to retract the source into its shielded safe after a bronchial
catheter has been pulled out of the clamping adapter. They subsequently sent
a letter dated August 18, 1995, (Attachment 3) to all 12i users, advising them
to discontinue use of these adapters. The letter further advised the users
that new clamping adapters were in production and would be provided to them in
October 1995.
NRC is concerned about the possibility of ether patients or licensee staff
receiving excessive exposures to radiation if an HDR source fails to retract.
Because of this documented defect in the GammaMed 12i bronchial clamping
adapters, all affected licensees are encouraged to follow the recommendations
of the device vendor, as contained in its letter of August 18, 1995. Any
licensee using this adapter to complete a course of treatment started before
the vendor's notification should exercise extreme caution.
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
Technical Contact:
Robert L. Ayres, NMSS
Attachments: (301) 415-5746 77
1. BARKER+ TECH-TIP, dated November 22, 1994
2. BARKER+ TECH-TIP, dated July 18, 1995
3. BARKER+ Letter, dated August 18, 1995
4. List of Recently Issued NMSS Information Notices
5. List of Recently Issued NRC Information Notices DOC NAME: 95-50.IN
OFC IMABl1 IMAB lEIMAB lC; IMOB I Cl
NAME *RAyres *JMPICCONE *LWCamper *RBaer *GPangbun
DATE 10/16/95 1 9/19/95 9/19/95 9/20/95 9/20/95
. .
AFf Ivanw
TarhFd
An.,.
I I A___ _ __ _
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__ _ __ _ I _ ___
I- DDIIMNS
.________________________,_
I I D/IMNS
_,_________________________..
I
KNAE *EKrause *STreby *FCCombs *DACool
9/21/95 10/02/95 10/12/95 10/17/95 _
IN
September , 1995 /
After the second incident in July 1995, Frank Barker Associates ,'nc., issued
two more notifications, to its customers on the use of the 1.8Am bronchial
catheter clamping adapters, Product Number 931-012. The first of these
(Attachment 2) was another BARKER+ TECH-TIP, dated July 18, A995, which
advised customers to avoid the "end test" mode of operati with the white
1.8-mm bronchial catheter, as this mode will stretch the/catheter and possibly
push the catheter out of the clamping adapter. This TOtH-TIP goes on to
describe the sticking of the source, in the clamping adapter, should the
catheter be pushed out of the adapter. /
Frank Barker Associates, Inc. also held discussiW< with the NRC, regarding
radiation safety issues associated with the fal ure of the GammaMed 12i
devices to retract the source into its shield d safe after a bronchial
catheter has been pulled out of the clampin adapter. They subsequently sent
a letter dated August 18, 1995, (Attachmen 3) to all 12i users, advising them
to discontinue use of these adapters. The letter further advised the users
that new clamping adapters were in prodution and would be provided to them in
October 1995. /
NRC is concerned about the possibil, 4y of ether patients or licensee staff
receiving excessive exposures to diation if an HDR source fails to retract.
Because of this documented defe in the GammaMed 12i bronchial clamping
adapters, all affected license s are encouraged to follow the recommendations
of the device vendor, as con ned in its letter of August 18, 1995. Any
licensee using this adapter o complete a course of treatment started before
the vendor's notification ould exercise extreme caution.
This information notice requires no specific action nor written response. If
you have any question about the information in this notice, please contact
the technical contac 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
Technical ontact: Robert L. Ayres, NMSS
(301) 415-5746 Attach nts:
1. BAKER+ TECH-TIP, dated November 22, 1994
2. ARKER+ TECH-TIP, dated July 18, 1995
3. BARKER+ Letter, dated August 18, 1995
4 List of Recently Issued NMSS Information Notices
- . List of Recently Issued NRC Information Notices G:\Gammamed.In
See Previous Concurrence
OF IMAB I Ofl IMAB I E IMB IC SSSS l MO IE
NAME RAyres ; j._4 *JMPICCONE *LWCamper *RBaer *GPangbun
DATE __ t
Is//95 1 9/19/95 9/19/95 A I
9/20/95 _ 9/20/95 I T
-
nrr I -.-.- TehFi II I OMC I I DD/IMNS I I QiJ4Nb.'o'I i
-. --- * -.
NAME *EKrause *STreby *FCCombs
DATE 9/21/95 10/02/95 10/12/95 tofe
/t /Its,
IN
September , 1995 After the second incident in July 1995, Frank Barker Associates, Inc., issued
two more notifications, to its customers on the use of the 1.8-mm bronchial
catheter clamping adapters, Product Number 931-012. The first of these
(Attachment 2) was another BARKER+ TECH-TIP, dated July 18, 1995, which
advised customers to avoid the *end test' mode of operation with the white
1.8-mm bronchial catheter, as this mode wUji stretch the catheter and possibly
push the catheter out of the clamping adapter. This TECH-TIP goes on to
describe the sticking of the source, in the clamping adapter, should the
catheter be pushed out of the adapter.
Frank Barker Associates, Inc. also held discussions with the NRC, regarding
radiation safety issues associated with the failure of the GammaMed 12i
devices to retract the source into its shielded safe after a bronchial
catheter has been pulled out of the clamping adapter. They subsequently sent
a letter dated August 18, 1995, (Attachment 3) to all 12i users, advising them
to discontinue use of these adapters. The letter further advised the users
that new clamping adapters were in production and would be provided to them in
October 1995.
NRC is concerned about the possibility of ether patients or licensee staff
receiving excessive exposures to radiation if an HDR source fails to retract.
Because of this documented defect in the GammaMed 12i bronchial clamping
adapters, all affected licensees are encouraged to follow the recommendations
of the device vendor, as contained in its letter of August 18, 1995. Any
licensee using this adapter to complete a course of treatment started before
the vendor's notification should exercise extreme caution.
Related Generic Communications:
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
Technical Contact:
Robert L. Ayres, NMSS
(301) 415-5746 Attachments:
1. BARKER+ TECH-TIP, dated November 22, 1994
2. BARKER+ TECH-TIP, dated July 18, 1995
3. BARKER+ Letter, dated August 18, 1995 IOFC
NAME
DATE
4. List of Recently Issued NMSS Information Notices
5. List of Recently Issued NRC Information Notices G:\Gammamed.In
LIMABEI r[Z-IK
OCIMAB
I.,oA/oi/95
.<
RAyresz *JMPICCONE
j9/19/95 I E
__
IfMAB
9/19/95
. I
3j§EZ~
-iIK
SS
9/20/95 FE
l
I
IMABlC
9/20/95 l
I
I- ---- A
nAr I TcrhFA I I Or/c I I WINS \II D/IMNS
NAME *EKrause *STreby FCZb I I DACool
DATE 9/21/95 10/02/95 \O/\"Y 11> / /
September , 1995 Following the second Incident in July 1995, Frank Barker Associates, Inc.,
issued two more notifications to their customers on the use of the 1.8mm
bronchial catheter clamping adapters, Product Number 931-012. The first of
these (Attachment 2) was another BARKER+ TECH-TIP dated July 18, 1995, advising their customers to avoid the 'end test' mode of operation with the
white 1.8mm bronchial catheter as this mode will stretch the catheter and
possibly push the catheter out of the clamping adapter. This TECH-TIP goes on
to describe the sticking of the source in the clamping adapter should the
catheter be pushed out of the adapter.
After discussions with the NRC, related to radiation safety issues associated
with the failure of the GammaMed 12i devices to retract the source into its
shielded safe after a bronchial catheter has been pulled out of the clamping
adapter, Frank Barker Associates, Inc., sent a letter dated August 18, 1995, (Attachment 3) to all 121 users advising them to discontinue use of these
adapters. The letter further advised their users that new clamping adapters
were in production and would be provided to them in October 1995.
The NRC is concerned about the potential for excessive exposures to radiation
by either patients, or licensee staff, in the event of the failure of an HDR
source to retract, due to this documented defect in the GammaMed 121 bronchial
clamping adapters. All affected licensees are encouraged to follow the
recommendations of the device vendor, as contained in their letter of
August 18, 1995. Extreme caution should be exercised by any licensee using
this adapter to complete a course of treatment that was started prior to the
vendor's notification.
Related Generic Communications:
This information notice requires no specific action or 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
Technical Contact:
Robert L. Ayres, NMSS
(301) 415-5746 Attachments:
1. BARKER+ TECH-TIP, dated November 22, 1994
2. BARKER+ TECH-TIP, dated July 18, 1995
3. BARKER+ Letter, dated August 18, 1995
4. List of Recently Issued NMSS Information Notices
5. List of Recently Issued NRC Information Notices G:\Gammamed.In
OFC
OFC I E IMAB OI
NAME RAyresmA4 =
_S__CNE_ aer __ __ _Wer G
DATE 9/1q/95 9/1Q/95 J,46 OWNq_ 1 X___ __a___ / /_5fi
OFm I TechEd I I It; LVW "'It I DDn1i NIM / I D/IMNS I
NAME EKrause 1 T DACool
DATE / fIJr / / _t
__/_
__ / /
2025175133 FETZEP-MUS, IMC. PAG 0'1
09/22i1995 1'1:29 SPD 20O95 17:17 No .010 P.04/0 4 TEL : 301-504-S369
INRC IMNS DIVISION
IN
uSptember , 1995 second incident In Jull 1965, Frank Barkar use Ascocites, t
issued two more notification to custwer*,Pn the of the .
bronchial catheter claping sxapters, Product Nd~cr 911-01t. The frt f
(Attachunt Z) wis another SARKEj+ TECH TIdatG4 July 18 ,
I95
- wstms to avoid the snd d of operation with the
e teZt
white 1. bronchial catheterS thIs mode stretch the catheter and
a ssbS sh the catheter ourof the clamping dapter. This TECH-TIP oes an
o des ths sticking of the %ource, th c&aping adaptev hoIld th
catheter be pushed out of the adapter.
1with H NRCve radiation safety IWMs associated
lure of the G ed 121 devices to retract the aource into its
ineAftar nchilecatheter has been pulled ou-LgL9I'e t i'
spurcqu Vw.I
clampng adapters. A-l .(roctad
rL, t,__
-.
re I enco
"1censee Ea
t
vncundations of the device vendor, as containad I
August 18. 1995. -6tk c..c ne
l&uAiosl'i
was cI
this adapter to complete a ceurso of treatment tht
vendor's notif1catioi, V"A Akb't"
- C (:: i.
Reltatd Gentric EJMOUflleAtiQi!
4,,
This tnformation notice requires no specific actt1thirnotie 6 PWritten response. If
you have any questions about the information in pitase contact
the technical contact listed below or the appropriate regiunaJ OffiCe.
Donald A.Cools Director
Division of Industrial 3W
Medical Nuclear Safety
Office of Nulear Material Safety
and Safegutrds
Technical Contact:
Robert L. Ayres, W4SS
(301) 415-5740
Attachments:
1. -AMVP4- TECH-TIP, dated November Us, 1994
2. BAKER+ TECN-TIP, dated July 18. 19S
3. 8ARXER+ Letter, daid August 18, 1495
4. List of Recently Issued NSS Infofmation Notices
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UPG ERULNU I _______________ -
-N I EIre M by F~combs DAC001
'4) I
IN 95-50
October 30, 1995 After the second incident in July 1995,-Frank Barker Associates, Inc., issued
two more notifications, to its customers on the use of the 1.8-mm bronchial
catheter clamping adapters, Product Number 931-012. The first of these
(Attachment 2) was another BARKER+ TECH-TIP, dated July 18, 1995, which
advised customers to avoid the lend test" mode of operation with the white
1.8-mm bronchial catheter, as this mode will stretch the catheter and possibly
push the catheter out of the clamping adapter. This TECH-TIP goes on to
describe the sticking of the source, in the clamping adapter, should the
catheter be pushed out of the adapter.
Frank Barker Associates, Inc. also held discussions with the NRC, regarding
radiation safety issues associated with the failure of the GammaMed 121 devices to retract the source into its shielded safe after a bronchial
catheter has been pulled out of the clamping adapter. They subsequently sent
a letter dated August 18, 1995, (Attachment 3) to all 12i users, advising them
to discontinue use of these adapters. The letter further advised the users
that new clamping adapters were in production and would be provided to them in
October 1995.
NRC is concerned about the possibility of ether patients or licensee staff
receiving excessive exposures to radiation if an HDR source fails to retract.
Because of this documented defect in the GammaMed 12i bronchial clamping
adapters, all affected licensees are encouraged to follow the recommendations
of the device vendor, as contained in its letter of August 18, 1995. Any
licensee using this adapter to complete a course of treatment started before
the vendor's notification should exercise extreme caution.
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.
2,&/ 'I
Donald A. Cool, Director
Division of Industrial and
Medical Nuclear Safety
Office of Nuclear Material Safety
and Safeguards
Technical contact: Robert L. Ayres, NMSS
(301) 415-5746 Attachments:
1. BARKER+ TECH-TIP, dated November 22, 1994
2. BARKER+ TECH-TIP, dated July 18, 1995
3. BARKER+ Letter, dated August 18, 1995
4. List of Recently Issued NMSS Information Notices
5. List of Recently Issued NRC Information Notices
ar.
Attachment 1 IN 95-50
October 30, 1995 B A R K E R+ T EC H - T I P
DATE: November 22. 1994 TO: All GAMMAMED 12i Users
FROM: Garry Nixon - U.S. GAMMAMED Service Manager
RE: GAMMAMED 12i Bronchial Catheters and Clamping Adapters
For the safest operation of your GAMMAMED 12i HDR unit please follow the following
procedures when using the white 1.8mm bronchial catheter with its associated damping
adapter.
The proper procedure before inserting the damping adapter into the treatment head is:
1) depre" the end of the dcamping adapter,
2) insert the white 1.8mm catheter Into the damping adapter as far as It will go,
3) release the end of the damping adapter,
4) Zull on the end of the damping adapter while holding it as illustratfd below to iocke it
firmly on the catheter,
6) now inset the damping adapter Into the treatment head.
Old Stc
alamping Adapter
hold pull to lock
hace
Uew Style
Camping Adapter
hold_ pull to loclc
heme
In order to avoid the catheter being pulled from the damping adapter In the case of the
patient moving, insure that slack exists in the catheter between the patent and the HOR
treatment head. This will be facilitated by positioning the tre3anent unit as near ac Is
possible to the patient.
If you have any questions please contact me at our toll-free number 1-800-2-BARKER
a - -
Attachment 2 IN 95-50
October 30, 1995 BARKER+ TECH-TIP
DATE: July 18, 1995 TO: Al Gammmed 12i Users
FROM: Garry Nixon - U.S. Iammned Service Manager
RE: Bronclal catheters to be used p in indexer chamncls 20 -24 I would like to remind all Gtmamed 12i Users that whaeever using the white 1.8mm
bronchial cathctcr, that this catheter will stretch if a duznry wire 'end test' is performed.
This will most likely cause the console eror message "Probe too long in channe 1".
There is also the distinct possibility that in the process of the dummy wire pushing
against the end of the catheter, it will push the catheter almost completely out of the meul
clamping adapte which connects the catheter to the 12i's indexer channeL It is possible
that the source could complet.ly pubh the cathctcr out of the clamping adaptcr which
would result in the clanping adapter no longer clamping on the catheter but rather
clamping on the source wire! During the next movement of the source wire, the
abnormally high amount of frictin (between the cliapiig auapter and the source wire)
will be detected and an Emergency Ret will be initiated, thus terminating the
treatment. lf; during this Emergency Reawt, the wire becomes saLk in Lhe clump, it may
not be possible to completely retact the source capsule into it's "safe' position in the
depleted uranium shielding. This obviously would necessitate intervention within the
nmument room by the Radiation Oncology staff conducting the treatment, to evacuate the
patent; and by a BARKER+ Servce Egineer to retrieve the source into the shielding or
a shipping container.
In o to avoid this scrio,it iiimp at s adapter b used in indexer
channels 1-19. ThcIc ubwwels ae pvogmramcd to do an end t1st with c dummy
before extending the source wire. Chnels 20-24 do not do this end test and were
designed this way to be used with this catheter/clamping adapter applicator.
if you have any questions please contact me at ow toll-free number 1-800-2-BARKER-
& -
Attachment 3 IN 95-50
October 30, 1995 BARKER+
Sales and Marketing Division
33 JacktsonvlltG Road, Bldg.#1 Towaco, NJ 07082 Phone: (800) 222-7637 FAX.: (201) 335-1225 Date: August 18, 1995 To:
ATTN:'
From:Jeff Stickler
Number of Pages including this one: 1 all 12i Users that are presently usinq
the
Frank Rarker Associates. Inc. hereby advises new style, to discontinue use of
number 931-012, either old style or
12i damping adapter, product would
treating a patient using these adapters. we
these adapters. However. if ynt Art presently if you have one and or; 2)
advise that you finish treatments: 1)using the old style adapter
which we supplied to hp nprtain that the adapter is in the locked position.
following the Tech Tops
the NR(^ and the manufacturer.
This docision was made after discussion with which will become available in
in production
ITSiGAMAMED has a new clamping adapter of these specific adapters free of charge tn
the
Octor 1096. At tfat time we will replace any
Users.
please contact Jeff Stickier at the above
If you have any questions regarding this matter
convenience.
toll-free number and exton5o;n. 608 ot your
Respectfully, jusfley C. Sticger
Oirector Customer Support
Extension 608
a .
Attachment 4 IN 95-50
October 30, 1995 LIST OF RECENTLY ISSUED
NMSS INFORMATION NOTICES
Information Date of
Notice No. Subject Issuance Issued to
95-44 Ensuring Combatible Use of 09/26/95 All Radiography Licensees.
Drive Cables Incorporating
Industrial Nuclear Company
Ball-type Male Conectors
95-39 Brachytherapy Incidents 09/19/95 All U.S. Nuclear Regulatory
Involving Treatment Commission Medical
Planning Errors Licensees.
95-29 Oversight of Design and 06/07/95 All holders of OLs or CPs
and Fabrication Activities for nuclear power reactors.
for Metal Components Used
in Spent Fuel Dry Storage Independent spent fuel
Systems storage installation
designers and fabricators.
95-28 Emplacement of Support 06/05/95 All holders of OLs or CPs
Pads for Spent Fuel Dry for nuclear power reactors
Storage Installations at
Reactor Sites
95-25 Valve Failure during 05/11/95 All U.S. Nuclear Regulatory
Patient Treatment with Commission Medical
Gamma Stereotactic Licensees.
Radiosurgery Unit
94-64, Reactivity Insertion Trans- 04/06/95 All holders of OLs or CPs
Supp. 1 ient and Accident Limits for Nuclear Power Reactors
for High Burnup Fuel and all fuel fabrication
licensees.
95-07 Radiopharmaceutical Vial 01/27/95 All U.S. Nuclear Regulatory
Breakage during Preparation Commission medical licensees
authorized to use byproduct
material for diagnostic
procedures.
95-01 DOT Safety Advisory: 01/04/95 All U.S. Nuclear Regulatory
High Pressure Aluminum Commission licensees.
Seamless and Aluminum
Composite Hoop-Wrapped
Cylinders
K-,
V 6 .
Attachment 5 IN 95-50
October 30, 1995 Page I of 1 LIST OF RECENTLY ISSUED
NRC INFORMATION NOTICES
Information Date of
Notice No. Subject Issuance Issued to
95-49 Seismic Adequacy of 10/27/95 All holders of OLs or CPs
Thermo-Lag Panel s for nuclear power reactors.
95-48 Results of Shift Staffing 10/10/95 All holders of OLs or CPs
Study for nuclear power reactors.
95-47 Unexpected Opening of a 10/04/95 All holders of OLs or CPs
Safety/Relief Valve and for nuclear power reactors.
Complications Involving
Suppression Pool Cooling
Strainer Blockage
95-46 Unplanned, Undetected 10/06/95 All holders of OLs or CPs
Release of Radioactivity for nuclear power reactors.
from the Exhaust Ventilation
System of a Boiling Water
Reactor
95-12, Potentially Nonconforming 10/05/95 All holders of OLs or CPs
Supp. 1 Fasteners Supplied by for nuclear power reactors.
A&G Engineering II, Inc.
95-45 American Power Service 10/04/95 All holders of OLs or CPs
Falsification of American for nuclear power reactors.
Society for Nondestructive
Testing (ASNT) Certificates
95-44 Ensuring Compatible Use of 09/26/95 All Radiography Licensees.
Drive Cables Incorporating
Industrial Nuclear Company
Ball-Type Male Connectors
95-43 Failure of the Bolt-Locking 09/28/95 All holders of OLs or CPs
Device on the Reactor for nuclear power reactors
Coolant Pump Turning Vane designed by Westinghouse
Electric Corporation (W).
95-42 Commission Decision on the 09/22/95 All holders of OLs or CPs
Resolution of Generic for nuclear power reactors.
Issue 23, NReactor Coolant
Pump Seal Failure'
OL - Operating License
CP - Construction Permit
|
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|
list | - Information Notice 1995-01, DOT Safety Advisory: High Pressure Aluminum Seamless and Aluminum Composite Hoop-Wrapped Cylinders (4 January 1995, Topic: Brachytherapy)
- Information Notice 1995-02, Problems With General Electric CR2940 Contact Blocks In Medium-Voltage Circuit Breakers (17 January 1995)
- Information Notice 1995-02, Problems With General Electric Cr2940 Contact Blocks In Medium-Voltage Circuit Breakers (17 January 1995)
- Information Notice 1995-02, Problems with General Electric CR2940 Contact Blocks in Medium-Voltage Circuit Breakers (17 January 1995)
- Information Notice 1995-03, Loss of Reactor Coolant Inventory and Potential Loss of Emergency Mitigation Functions While in a Shutdown Condition (18 January 1995, Topic: Packing leak, Water hammer)
- Information Notice 1995-04, Excessive Cooldown and Depressurization of the Reactor Coolant System Following Loss of Offsite Power (11 October 1996, Topic: Safe Shutdown, Shutdown Margin, Probabilistic Risk Assessment, Troxler Moisture Density Gauge)
- Information Notice 1995-05, Undervoltage Protection Relay Settings Out of Tolerance Due to Test Equipment Harmonics (20 January 1985)
- Information Notice 1995-06, Potential Blockage of Safety-Related Strainers by Material Brought Inside Containment (25 January 1995, Topic: Foreign Material Exclusion)
- Information Notice 1995-07, Radiopharmaceutical Vial Breakage During Preparation (27 January 1995)
- Information Notice 1995-08, Inaccurate Data Obtained with Clamp-On Ultrasonic Flow Measurement Instruments (30 January 1995)
- Information Notice 1995-08, Inaccurate Data Obtained With Clamp-On Ultrasonic Flow Measurement Instruments (30 January 1995)
- Information Notice 1995-09, Use of Inappropriate Guidelines and Criteria for Nuclear Piping and Pipe Support Evaluation and Design (31 January 1995, Topic: Operability Determination)
- Information Notice 1995-10, Potential for Loss of Automatic Engineered Safety Features Actuation (3 February 1995, Topic: High Energy Line Break)
- Information Notice 1995-11, Failure of Condensate Piping Because of Erosion/Corrosion at Flow-Straightening Device (24 February 1995, Topic: Feedwater Heater)
- Information Notice 1995-12, Potentially Nonconforming Fasteners Supplied by A&G Engineering II, Inc (21 February 1995)
- Information Notice 1995-13, Potential for Data Collection Equipment to Affect Protection System Performance (24 February 1995)
- Information Notice 1995-14, Susceptibility of Containment Sump Recirculation Gate Valves to Pressure Locking (28 February 1995)
- Information Notice 1995-15, Inadequate Logic Testing of Safety-Related Circuits (7 March 1995)
- Information Notice 1995-16, Vibration Caused by Increased Recirculation Flow in a Boiling Water Reactor (9 March 1995)
- Information Notice 1995-17, Reactor Vessel Top Guide and Core Plate Cracking (10 March 1995, Topic: Safe Shutdown, Intergranular Stress Corrosion Cracking, Stress corrosion cracking)
- Information Notice 1995-18, Potential Pressure-Locking of Safety-Related Power-Operated Gate Valves (15 March 1995)
- Information Notice 1995-19, Failure of Reactor Trip Breaker to Open Because of Cutoff Switch Material Lodged in the Trip Latch Mechanism (22 March 1995)
- Information Notice 1995-20, Failures in Rosemount Pressure Transmitters Due to Hydrogen Permeation Into Sensor Cell (22 March 1995)
- Information Notice 1995-21, Unexpected Degradation of Lead Storage Batteries (20 April 1995)
- Information Notice 1995-22, Hardened or Contaminated Lubricant Cause Metal-Clad Circuit Breaker Failures (21 April 1995, Topic: Hardened grease)
- Information Notice 1995-23, Control Room Staffing Below Minimum Regulatory Requirements (24 April 1995)
- Information Notice 1995-24, Summary of Licensed Operator Requalification Inspection Program Findings (25 April 1995, Topic: Job Performance Measure, License Renewal)
- Information Notice 1995-25, Valve Failure During Patient Treatment with Gamma Stereotactic Radiosurgery Unit (11 May 1995, Topic: Overdose)
- Information Notice 1995-26, Defect in Safety-Related Pump Parts Due to Inadequate Treatment (31 May 1995, Topic: Intergranular Stress Corrosion Cracking, Stress corrosion cracking)
- Information Notice 1995-27, NRC Review of Nuclear Energy Institute, Thermo-Lag 330-1 Combustibility Evaluation Methodology Plant Screening Guide. (31 May 1995, Topic: Safe Shutdown, Fire Barrier, Exemption Request, Fire Protection Program)
- Information Notice 1995-28, Emplacement of Support Pads for Spent Fuel Dry Storage Installations at Reactor Sites (5 June 1995, Topic: Safe Shutdown, Tornado Missile, Safe Shutdown Earthquake, Earthquake)
- Information Notice 1995-29, Oversight of Design and Fabrication Activities for Metal Components Used in Spent Fuel Dry Storage Systems (7 June 1995, Topic: Nondestructive Examination)
- Information Notice 1995-30, Susceptibility of Low-Pressure Coolant Injection Valves to Pressure Locking (3 August 1995, Topic: Hydrostatic, Power-Operated Valves, Overspeed)
- Information Notice 1995-31, Motor-Operated Valve Failure Caused by Stem Protector Pipe Interference (9 August 1995, Topic: Overspeed)
- Information Notice 1995-32, Thermo-Lag 330-1 Flame Spread Test Results (10 August 1995, Topic: Fire Barrier, Overspeed)
- Information Notice 1995-33, Switchgear Fire and Partial Loss of Offsite Power at Waterford Generating Station, Unit 3 (23 August 1995, Topic: Overspeed)
- Information Notice 1995-34, Air Actuator and Supply Air Regulator Problems in Copes-Vulcan Pressurizer Power-Operated Relief Valves (25 August 1995, Topic: Overspeed)
- Information Notice 1995-35, Degraded Ability of Steam Generators to Remove Decay Heat by Natural Circulation (28 August 1995, Topic: Overspeed)
- Information Notice 1995-36, Potential Problems with Post-Fire Emergency Lighting (29 August 1995, Topic: Safe Shutdown, Emergency Lighting, Exemption Request, Overspeed, Manual Operator Action)
- Information Notice 1995-37, Inadequate Offsite Power System Voltages During Design-Basis Events (7 September 1995)
- Information Notice 1995-38, Degradation of Boraflex Neutron Absorber in Spent Fuel Storage Racks (8 September 1995)
- Information Notice 1995-39, Brachytherapy Incidents Involving Treatment Planning Errors (19 September 1995, Topic: Brachytherapy, Underdose)
- Information Notice 1995-40, Supplemental Information to Generic Letter 95-03, Circumferential Cracking of Steam Generator Tubes. (20 September 1995, Topic: Hydrostatic, Nondestructive Examination, Brachytherapy)
- Information Notice 1995-41, Degradation of Ventilation System Charcoal Resulting from Chemical Cleaning of Steam Generators (22 September 1995, Topic: Brachytherapy)
- Information Notice 1995-42, Commission Decision on Resolution of Generic Issue 23, Reactor Coolant Pump Seal Failure. (22 September 1995, Topic: Brachytherapy)
- Information Notice 1995-43, Failure of Bolt-Locking Device on Reactor Coolant Pump Turning Vane (28 September 1995, Topic: Brachytherapy)
- Information Notice 1995-44, Ensuring Compatible Use of Drive Cables Incorporating Industrial Nuclear Company Ball-Type Male Connectors (26 September 1995, Topic: Brachytherapy)
- Information Notice 1995-45, American Power Service Falsification of American Society for Nondestructive Testing Certificates (4 October 1995, Topic: Commercial Grade, Brachytherapy)
- Information Notice 1995-46, Unplanned, Undetected Release of Radioactivity from the Exhaust Ventilation System of a Boiling Water Reactor (6 October 1995, Topic: Brachytherapy)
- Information Notice 1995-47, Unexpected Opening of a Safety/Relief Valve & Complications Involving Suppression Pool Cooling Strainer Blockage (30 November 1995)
... further results |
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