The following was received from the Commonwealth of
Massachusetts via e-mail:
On 2/12/10, licensee reported to this Agency [Commonwealth of Massachusetts] the 2/11/10 discovery of a medical event that occurred on 2/10/10. The situation [was] described as two treatment fraction underdoses, delivered on the same day to the same patient, that differed from the prescribed dose, per fraction, by more than 50%. Initial indication [is] that [the] event was caused by [an] equipment software bug. Two fractions of 0.4 Gy were delivered on the first day of treatment. The prescription was for two treatments of 4 Gy per fraction per day for two days and one final 4 Gy treatment on the third day. [The] prescribing physician and equipment manufacturer [were] notified. This is a preliminary report; investigation [is] ongoing; more information to follow.
The Agency considers this event OPEN and ONGOING.
- * * UPDATE FROM TONY CARPENITO TO JOE O'HARA VIA E-MAIL AT 1007 ON 2/17/10 * * *
[The] equipment manufacturer found the software issue to be 'reproducible' and therefore may be classified as a 'potential' (patient) safety issue.
[The] suspect portion of software will not be used again until [the] program [is] debugged and documented to be correct. [The] suspect portion of the software had not been used in the past by the licensee; no previous patients were affected.
The device has been identified as a Nucletron HDR V3, and the software program is named Oncentra.
Event docket #02-8893.
Notified R1DO(T. Jackson) and FSME EO(McIntosh)
- * * UPDATE FROM TONY CARPENITO TO HUFFMAN VIA E-MAIL AT 1448 ON 3/23/10 * * *
The equipment manufacturer published a customer information bulletin describing the problem. The licensee submitted a formal follow-up report to this Agency [Commonwealth of Massachusetts] on 2/25/10. The licensee wrote that since the underdose could be made up there will be no effect on the treatment outcome. There is no radiation morbidity. Patient underdose on 2/10/10 was 90%. The Agency considers this matter to be closed.
Notified R1DO(Caruso) and FSME EO(Kock).
A Medical Event may indicate potential problems in a medical facility's use of radioactive materials. It does not necessarily result in harm to the patient.