ENS Event | |
|---|---|
05:00 Feb 10, 2010 | |
| Title | Agreement State Report - Potential Medical Event Due to Underdose Greater than 50% |
| Event Description | 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.
[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)
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. 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. |
| Where | |
|---|---|
| Mass General Hospital Boston, Massachusetts (NRC Region 1) | |
| License number: | 60-0055 |
| Organization: | Ma Radiation Control Program |
| Reporting | |
| Agreement State | |
| Time - Person (Reporting Time:+53.75 h2.24 days <br />0.32 weeks <br />0.0736 months <br />) | |
| Opened: | Tony Carpenito 10:45 Feb 12, 2010 |
| NRC Officer: | Joe O'Hara |
| Last Updated: | Mar 23, 2010 |
| 45695 - NRC Website | |
Mass General Hospital with Agreement State | |
WEEKMONTHYEARENS 456952010-02-10T05:00:00010 February 2010 05:00:00
[Table view]Agreement State Agreement State Report - Potential Medical Event Due to Underdose Greater than 50% 2010-02-10T05:00:00 | |