PNO-II-93-073A, updates Info Contained in PNO-II-93-073 Re Misadministration Using microselection-HDR Device,Resulting from Lack of Realization by Licensee Personnel That Gynecological Transfer Tubes Being Used Longer in Length
| ML20059B992 | |
| Person / Time | |
|---|---|
| Issue date: | 12/21/1993 |
| From: | NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION II) |
| To: | |
| References | |
| PNO-II-93-073A, PNO-II-93-73A, NUDOCS 9401040323 | |
| Download: ML20059B992 (1) | |
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, December 21, 1993 PRELIMINARY NOTIFICATION OF EVENT OR UNUSUAL OCCURRENCE PNO-II-93-073A 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.
Fncility Licensee Emergency Classification Mt. Sinai Medical Center Notification of Unusual Event Greater Miami Alert Miami, Florida Site Area Emergency i
Miami, Florida General Emergency License No:
FL-64-12 X Not Applicable
Subject:
UPDATE, MISADMINISTRATION USING MICROSELECTRON-HDR DEVICE This PN updates the information contained in PNO-II-93-073 with information reported by the licensee, Mount Sinai Medical Center, to the State of Florida on December 16, 1993.
The misadministration appears to have resulted from the lack of realization by licensee personnel that the gynecological transfer tubes being used were longer in length (1.5 m) than other transfer tubes which were 1.0 m in length.
This resulted in the source being located approximately.5 m short of the intended treatment site.
Neither the standard transfer tubes nor the longer transfer tubes were identified with respect to length.- The version of software supplied by Nucletron for the treatment planning computer does not support the longer transfer tube length of 150 cm.
The radiation dose to the skin of the knee area (closest to the soarce, approximately
.3 m) of seven of the eight patients is estimated to be 3.6 rad per treatment, with each patient receiving 2 to 4 treatments.
One patient, however, has evidence of skin erythema due to radiation in the knee area.
The dose to this area is estimated to be 4000 - 6000 rads.
The State of Florida, OSP and NMSS staff discussed the incident on December 17, 1993, and confirmed that the licensee and device manufacturer, Nucletron, had instituted corrective actions that were sufficient to preclude a near-term recurrence.
Discussions among the Florida, OSP, and NMSS staffs occurred on December 20, 1993 to identify additional information needs and plan for another State of Florida inspection of the licensee to begin on December 21, 1993.
The State of Florida will inform NRC of the newly developed information in this case and provide the NRC with copies of additional licensee or manufacturer reports and the reports of Florida inspections.
This information is current as of 11:00 a.m.,
December 21, 1993.
Contact:
R.
E. Trojanowski (404)331-5597 j
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