Information Notice 1995-25, Valve Failure During Patient Treatment with Gamma Stereotactic Radiosurgery Unit

Valve Failure During Patient Treatment with Gamma Stereotactic Radiosurgery Unit

ML031060184
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:	05/11/1995
From:	Cool D NRC/NMSS/IMNS
To:
References
IN-95-025, NUDOCS 9505050171
Download: ML031060184 (9)

v1A I . -

UNITED STATES

NUCLEAR REGULATORY CONMISSION

OFFICE OF NUCLEAR MATERIAL SAFETY AND SAFEGUARDS

WASHINGTON, D.C. 20555 May 11, 1995 NRC INFORMATION NOTICE 95-25: VALVE FAILURE DURING PATIENT TREATMENT WITH

GAMMA STEREOTACTIC RADIOSURGERY UNIT

gAd-!ressees

All U.S. Nuclear Regulatory Comission Medical Licensees.

Purpose

The U.S. Nuclear Regulatory Commission (NRC)inwhich is issuing this information

notice to alert addressees to an incident the patient couch of a

Leksell Gam System Model 23016 ('ganna knife*) unit failed to retract from

the treatment position because of a failure of a two-position solenoid- operated valve on the hydraulic system of the unit. It is expected that

recipients will review the information foravoid applicability to their facilities

and consider actions, as appropriate, to noticesimilar problems. However, suggestions contained inthis information response isrequired.are not new NRC requirements;

therefore, no specific action nor written

Descriotion of Circumstances

NRC was notified of an incident that occurred at an Agreement State licensee

inwhich a patient undergoing gamma stereotactic radiosurgery received a dose, for a single fraction, that was 127 percent greater than the dose prescribed

for that fraction. On October 25, 1994, a System patient was prescribed to receive a

series of 10 exposures ina Leksell Gamna the patient Model 23016 f"gamna knife*)

unit. At the end of the sixth exposure, couch f i1ed to retract

of failure of a two-. tion, solenoid- from the treatment position because a

of the unit.

operated valve on the hydraulic system

The licensee's staff attempted to: (I)manually pump the hydraulic system;

and (2) shut the unit off. The latter action would normally turn the pump on

and direct the pressure to allow the bed to retract. However, inthis case, and the Internal spring could not

the valve was stuck inthe 'bed-in' positionThe valve failure disabled both the

reset the valve to allow the bed to move. on the unit, resulting

normal and primary emergency patient retraction systems

3.8 minutes longer than the intended

Inthe patient being irradiated forpersonnel

3-minute treatment time. Medical entered the room, pulled a

were able to move the bed

pressure equalization latch on the bed, and Subsequently, approximately 50 centimeters (20 inches). remove the patient they manually

from the treatment

disconnected the helmet from the unit to of the

room. The U.S. distributor, Elekta Radiosurgery,distributor notified

Inc., was

also notified all

event and subsequently replaced the valve. itThe to a valve failure, with no

Its customers of the event and attributed

specific information on the cause of the failure.

9505050171 A ,

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As1.R*. .

IN 95-25

'lay 11, 1995 At the request of the State of Georgia (Elekta Radlosurgery, Engineering Inc., is located

in Georgia), NRC, through a contract with the Idaho National The INEL

Laboratory (IEL), conducted a root-cause analysis of the incident. physicist, medical

team was comprised of a mechanical engineer, risk analyst, and radiation oncologist.

Discussin

The findings of the INEL report indicate that the cause offluid the valve failure

contaminants in the hydraulic system, which

was the existence of metal or scored the

either became caught between the valve spool and valve body It appears that

spool, thereby locking the valve in the bed-in' position. and rubber

during installation, several months before, pieces of dirt, metal, cleaned from

that are typically found in new hydraulic hoses were not properly

that were

one of the hoses. The report concluded that otheraremachines less likely to have a

installed before and have been cycled repeatedly a concern for the

similar failure; however, this type of failure remains

installation of new machines.

the

When the patient couch failed to retract, the facility staff toreleased the lowest

latch at the foot of the couch, thereby dropping the helmet When the helmet

position corresponding to the low point of the couch track.

of the primary

Is at the low point, the maximum dose rate at the focus percent of the dose rate at

10

collimator through the helmet is approximately alignment

the treatment position because of the lack of with the helmet

openings. Although the one exposure delivered a 127 percent overdose, it was

of the complete target volume with the result

delivered to a partial volume target within the

that there was a slight increase in the percentage of the

minor at the

45 percent isodose. However, changes in the isodose contour were to the patient

20 percent isodose contour. The maximum total dose delivered (fractions),

was approximately 33.5 Gray (Gy) (3350 rads) forrads), all 10 exposures

dose of 33.33 Gy (3333 therefore the medical

compared with a planned it appears that the

consequences of this incident are minimal. Furthermore, received less than 0.03 mSv

medical staff who responded to the emergency all

(3 mrem) each.

The report provides several recommendations: 1) to further the reduce the

failure of the kind experienced at facility, any

possibility of a repeat filter;

proposed design change should include installation of a 20-micronnew unit

2) a one-time laboratory analysis of hydraulic fluid after each

gamma knife

installation in addition to such analysis of, at least five other obtain a second

users should

units currently in operation; 3) all gamma knife the unit; 4) all gamma knife

emergency tool to disengage the head frame from

procedures to ensure they include

users should review their emergency

provisions in the event the bed fails to retract; and 5) review and retraining

of all emergency procedures with operating staff.

w.

IN 95-25 May 11, 1995 are requested to submit

As part of the licensing process, license applicants radiation exposure of

procedures for emergencies which could result in procedures for the gama

patients, workers, and the general public. Emergency

the hydraulic pressure is within

knife unit should address situations in which retract when the timer reaches

normal operating range, but the bed fails to should include procedures for

0.0. In addition, the emergency procedures the housing, using the long-handled

releasing the helmet from the trunnions in who may be installing

emergency tools provided by the manufacturer. Licensees for contamination of the

a gamma knife unit should be aware of the potential

hydraulic fluid.

nor written response. If

This information notice requires no specific action this notice, please contact

you have any questions about the information in NRC regional office.

the technical contact listed below, or the appropriate

Donald A. Cool, Director

Oisin of Industrial and

dical Nuclear Safety

Office of Nuclear Material

Safety and Safeguards

Technical contact: Patricia K. Holahan, NMSS

(301) 415-7847 Attachments:

Notices

1. List of Recently Issued NMSS Information Notices

2. 1ist of Recently Issued NRC Information

K>

Attachment 1 IN 95-25 may 11. 1995 tI-. ';: I Page I of I

I -  !~

..

LIST OF RECENTLY ISSUED

WSS INFORMATION NOTICES

.. in-formation Date of

,~

Subject Issuance Issued to

_o.c No.

tNotice No

..

Reactivity Insertion 04/06/95 All holders of OLs or CPs

94-64, for nuclear power reactors.

Supp. 1 Transient and Accident

Limits for High Burnup

Fuel

Radiopharmaceutical Vial 01/27/95 All U.S. Nuclear Regulatory

95-07 Commission medical licensees

Breakage during Preparation authorized to use byproduct

material for diagnostic

procedures.

DOT Safety Advisory: 01/04/95 All U.S. Nuclear Regulatory

95-01 Commission licensees.

High Pressure Aluminum

Seamless and Aluminum

Composite Hoop-Wrapped

Cylinders

Equipment Failures at 12/28/94 All U.S. Nuclear Regulatory

94-89 Commission Irradiator

Irradiator Facilities 1icensees.

Unauthorized Transfer of 12/07/94 All fuel cycle and material

89-25, licensees.

Rev. 1 Ownership or Control of

Licensed Activities

Accuracy of Bioassay 11/25/94 All U.S. Nuclear Regulatory

94-81 Commission licensees.

and Environmental

Sapling Results

Reporting Fuel Cycle 10/20/94 All 10 CFR Part 70

93-60, fuel cycle licensees.

Supp. 1 and Materials Events to

the NRC Operations Center

Facility Managefent 10/13/94 All U.S. Nuclear Regulatory

94-74 Commission Medical

Responsibilities for

Purchased or Contracted Licensees.

Services for Radiation

Therapy Programs

K)

Attachment 2 IN 95-25 May 11, 1995 Page I of I

LIST OF RECENTLY ISSUED

NRC INFORMATION NOTICES

information Date of

Notice No. Subject Issuance Issued to

Summary of Licensed 04/25/95 All holders of OLs or CPs

95-24 for nuclear power reactors.

Operator Requalification

Inspection Program

Findings

Control Room Staffing 04/24/95 All holders of OLs or CPs

95-23 for nuclear power reactors

Below minimum Regulatory and all licensed operators

Requirements and senior operators at

those reactors.

Hardened or Contaminated 04/21/95 All holders of OLs or CPs

95-22 for nuclear power reactors.

Lubricants Cause Metal

Clad Circuit Breaker

Failures

Unexpected Degradation 04/20/95 All holders of OLs or CPs

95-21 for nuclear power reactors.

of Lead Storage Batteries

Reactivity Insertion 04/06/95 All holders of OLs or CPs

94-64, for nuclear power reactors

Supp. 1 Transient and Accident

Limits for High Burnup

Fuel

Potential Pressure-Locking 03/31/95 All holders of OLs or CPs

95-18. for nuclear power reactors.

Supp. I of Safety-Related Power- Operated Gate Valves

Failures in Rosemount 03/22/95 All holders of OLs or CPs

95-20 for nuclear power reactors.

Pressure Transmitters

due to Hydrogen Per- meation into the Sensor

Cell

Failure of Reactor Trip 03/22/95 All holders of OLs or CPs

95-19 for nuclear power reactors.

Breaker to Open Because

of Cutoff Switch Material

Lodged in the Trip Latch

Mechanism

OL

• Operating License

CP

• Construction Permit

li :: 0

IN 95-25 May 11, 1995 As part of the licensing process, license applicants are requested to submit

procedures for emergencies which could result in radiation exposure of

patients, workers, and the general public. Emergency procedures for the gamma

knife unit should address situations in which the hydraulic pressure is within

normal operating range, but the bed fails to retract when the timer reaches

0.0. In addition, the emergency procedures should include procedures for

releasing the helmet from the trunnions in the housing, using the long-handled

emergency tools provided by the manufacturer. Licensees who may be installing

a gauma knife unit should be aware of the potential for contamination of the

hydraulic fluid.

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 NRC regional office.

Donald A. Cool, Director

Division of Industrial and

Medical Nuclear Safety

Office of Nuclear Material

Safety and Safeguards

Technical contact: Patricia K. Holahan, NMSS

(301) 415-7847 Attachments:

1. List of Recently Issued NHSS Information Notices

2. List of Recently Issued NRC Information Notices

DOC NAME: 95-25.IN

• See previous concurrence

To receiw a COpy of this docuent, Indicate In the box CwCopy w/o attchment/enctosure EnCopy wilth attchmentlenctosure K a go cwpy

OFFICE IMAB* IMAB* IMAB* Tech Ed*

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DATE 04/20/95 04/27/95 05/03/95 OFFICE D/IMNS*

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DATE 05/03/95

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IN 95- may , 1995 are requested to submit

As part of the licensing process, license applicants in radiation exposure of

procedures for emergencies which could resultEmergency procedures for the gamma

patients, workers, and the general public. pressure Is within

knife unit should address situations in which the hydraulic

normal operating range, but the bed fails to should retract when the timer reaches

Include procedures for

O.0. In addition, the emergency procedures using the long-handled

releasing the helmet from the trunnions in the housing, who may be installing

emergency tools provided by the manufacturer. Licensees for contamination of the

a gamma knife unit should be aware of the potential

hydraulic fluid.

nor written response. If

This information notice requires no specific action notice, please contact

you have any questions about the information in this NRC regional office.

the technical contact listed below, or the appropriate

Donald A. Cool, Director

Division of Industrial and

Medical Nuclear Safety

Office of Nuclear Material

Safety and Safeguards

Technical contact: Patricia K. Holahan, NMSS

(301) 415-7347 Attachments:

1. List of Recently Issued NMSS Information Notices

2. List of Recently Issued NRC Information Notices

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IN 95- April , 1995 Emergency procedures, for the gamma knife unit, should address ituations in

which the hydraulic pressure is within normal operatIng rang e , but the bed

fails to retract when the timer reaches 0.0. In addition, emergency

procedures should include procedures for releasing the he et from the

trunnions In the housing, using the long-handled emergey tools provided by

the manufacturer. Licensees who may be installing h draulic fluid. a nina knife unit should

be aware of the potential for contamination of the

This information notice requires no specific acti ihsnor written response. If

you have any questions about the information in notice, please contact

office.

the technical contact listed below, or the ap opriate NRC regional

Donald A Cool, Director

Divisi of Industrial and

Med al Nuclear Safety

Offt e of Nuclear Material

fety and Safeguards

Technical contact: Patricia . Holahan, NMSS

(301) 4 5-7847 Attachments:

1. List of Recently Iss d NMSS Information Notices

2. List of Recently Is ed NRC Information Notices

• See previous oncurrence _ No

OFC MA l AB c Tech Ed*l

NAME P Wbahan JMPlccone LWCamper EKraus

DATE / 414V95 03/27 95 03/30/95 03/10/95 OFt/ IM08 C OsS/;J& mlr.DIMNl_ EWBrach

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IN 95- March 1995 Licensees who possess a gamma knife unit should review their emerge y

procedures to ensure that they address situations In which the hy aulic

pressure is within normal operating range, but the bed fails to etract when

the timer reaches 0.0. In addition, operating staff should r lew emergency

procedures to include releasing the helmet from the trunnio in the housing, using the long-handled emergency tools provided by the man acturer.

Licensees who may be installing a gamma knife unit shoul be aware of the

potential for contamination of the hydraulic fluid.

This information notice requires no specific action or written response. If

you have any questions about the information in th s notice, please contact

the technical contact listed below, or the appro late NRC regional office.

Donald A. C 1, Director

Division o Industrial and

Medial Nuclear Safety

Office g Nuclear Material

Safey and Safeguards

Technical contact: Patricia K. olahan, NMSS

(301) 415-7 47 Attachments:

1. List of Recently Issued SS Information Notices

2. List of Recently Issued RC Information Notices

OFC IB kIL - - --EdI

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