ML19284A484
| ML19284A484 | |
| Person / Time | |
|---|---|
| Site: | 07001349 |
| Issue date: | 11/03/1978 |
| From: | NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION II) |
| To: | |
| Shared Package | |
| ML19284A480 | List: |
| References | |
| NUDOCS 7903060581 | |
| Download: ML19284A484 (1) | |
Text
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~ > 573 APPENDIX A NOTICE OF VIOLATION Hospital Pavia License No. SNM-1372 Based on the results of the NRC inspection conducted on September 27, 28, and 29, 1978, it appears that certain of your activities were not conducted in full compliance with NRC requirements as indicated below. '
These items have been categorized as described in our correspondence to you dated December 31, 1974.
A.
Condition 13 of your license requires that the licensee shall report to the Materials Branch, Directorate of Licensing, USSRC, Washington, D. C. 20545, within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> of occurrence, the death of any nuclear pacemaker bearer, and any adverse reaction and/or malfunction involving a pacemaker system, including the leads.
A written report giving details of the adverse reaction and/or malfunction shall be submitted within 30 days.
Contrary to the above, a patient implanted with a plutonium-238 pacemaker died in November, 1977; whereas, the NRC was not notified within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> of the occurrence and a written report giving the details was not provided until Septecber 29, 1978.
This is an infraction.
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