MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1998-04-29 for SYNCOR INTERNATIONAL 1990 MODEL manufactured by Syncor International.
[19073925]
Nine (9) pediatric pts rec'd a greater dose of gallium 67 than was ordered. This was discovered in or about 1/1/98. Causes include: 1. Default process of equipment (software). 2. Lack of understanding by staff of the default process. Note: facility does not anticipate any injury to the pts, however, felt if was important to report. Follow up when the problem was discovered included: 1. The incident was reported to the state dept of nuclear safety. 2. The pt's parents and attending physicians were notified. 3. Syncor int'l, the mfr, was notified and consulted. Note: syncor has not provided an undated operator's manual despite implementation of software updates and a request for same subsequent to discovery of this incident. 4. Corrective action taken included: a) the default programming was overriden. B) inservice education was conducted for staff. C) a practicum exam was designed to ensure operator proficiency. D) the procedure was modified to require that a physician sign for approval of pediatric doses. 5. Expert opinion was requested and rec'd from a univ med ctr.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1013655 |
| MDR Report Key | 165293 |
| Date Received | 1998-04-29 |
| Date of Report | 1998-04-21 |
| Date of Event | 1998-01-01 |
| Date Added to Maude | 1998-05-04 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SYNCOR INTERNATIONAL |
| Generic Name | UNIT DOSE MANAGER (SOFTWARE) |
| Product Code | KPT |
| Date Received | 1998-04-29 |
| Model Number | 1990 MODEL |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 160878 |
| Manufacturer | SYNCOR INTERNATIONAL |
| Manufacturer Address | 6464 CANOGA AVE. WOODLAND HILLS CA 913672407 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1998-04-29 |