PNO-II-93-073, on 931210,Region II Notified of Misadministration Event Involving Nucletron,microselectron- HDR Device Located at Mount Sinai Medical Ctr in Miami,Fl. Final Rept Under Preparation by Licensee
| ML20059C179 | |
| Person / Time | |
|---|---|
| Issue date: | 12/16/1993 |
| From: | Woodruff R NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION II) |
| To: | |
| References | |
| PNO-II-93-073, PNO-II-93-73, NUDOCS 9401040418 | |
| Download: ML20059C179 (2) | |
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- December 16, 1993 PRELIMINARY NOTIFICATION OF EVENT OR UNUSUAL OCCURRENCE PNO-II-93-073 This preliminary notification constitutes EARLY notice of events of POSSIBLE safety or public interest significance. The information is as initially received without verification or evaluation, and is basically all that is known by the Region II staff on this date.
FaciAity Licensee Empreency Classification Mt. Sinai Medical Center Notification of Unusual Event Greater Miami Alert l
Miami, Florida Site Area Emergency
(
Miami, Florida General Emergency License No:
FL-64-12 X Not Applicable
Subject:
MISADMINISTRATION USING MICROSELECTRON-HDR DEVICE Florida, an Agreement State, notified the Regional State Liaison Officer in Region II of a misadministration event involving a Nucletron, Microselectron-HDR device located at the Mount Sinai Medical Center of Greater Miami, Miami, Florida.
This is an Agreement State licensee and the telephone call was received on Friday, December 10, 1993.
Follow-up i
contacts with State representatives were made on December 13, 15, and this date by the Regional State Agreements Officer.
The therapy misadministrations took place at the licensee's facility during the period September 28 through November 24, 1993 and involved 22 treatments given to a total of 8 patients.
The number of treatments received by any one patient has not been confirmed at this point.
The treatments were for OBGYN procedures, but the dose was not delivered to the intended treatment site.
Preliminary information indicates that the patients knees received the greatest exposure and that each treatment could have delivered 3.6 rem to the surface of the knees.
l The preliminary investigation by the State indicates that the device contained 8 curies of Iridium-192.
Several source cables with two l
different lengths were being used by the licensee, and the cables were not identified by size (length). The cable length problem and licensee procedures were given as the most likely cause of the misadministrations.
A final report is under preparation by the licensee, and the State is continuing their investigation and possible other regulatory actions.
The State has contacted all of the other Florida "afterloader device" licensees by telephone and discussed the potential problems that could result from improper identification of cable lengths, and the failure to utilize adequate procedures during treatments.
There has been no news media interest reported as of this time.
This information is current as of 12:30 p.m.,
Thursday December 16, 1993.
030033 t/o 9401040418 931216 PDR I&E 3
&h 3 PNO-1I-93-073 PDR
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-Contact:
R. L. Woodruff i
(404)331-5553 t
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