MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2014-09-25 for MICROSELECTRON MHDR DIGITAL manufactured by Nucletron.
[4702172]
Information from the nrc report: a patient undergoing high dose rate brachytherapy using ir-192 was prescribed 700 cgy per fraction and only received 700 cgy to 60% of the planned volume. The patient was scheduled for two treatments. The first treatment was successfully administered to the patient on (b)(6) 2014. When the patient returned for the second treatment on (b)(6) 2014 the hdr afterloader was loaded with the treatment plan for the original treatment instead of the second treatment. This resulted in the patient not receiving the full prescribed treatment. The licensee discovered the problem during an audit when the number of catheters did not match. There are no adverse health effects expected as a result of this treatment.
Patient Sequence No: 1, Text Type: D, B5
[12166167]
Event caused by user. Additional information requested from hospital. Device not returned to the manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[23430491]
Event caused by user. No further information obtained from the customer.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9611894-2014-00001 |
| MDR Report Key | 4116601 |
| Report Source | 00 |
| Date Received | 2014-09-25 |
| Date of Report | 2014-10-16 |
| Date of Event | 2014-07-10 |
| Date Mfgr Received | 2014-08-28 |
| Date Added to Maude | 2014-09-25 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Street | LINAC HOUSE FLEMING WAY |
| Manufacturer City | CRAWLEY, WEST SUSSEX RH109RR |
| Manufacturer Country | UK |
| Manufacturer Postal | RH10 9RR |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MICROSELECTRON MHDR DIGITAL |
| Generic Name | SYSTEM, APPLICATOR, RADIONUCLIDE, REMOTE-CONTROLLED |
| Product Code | JAQ |
| Date Received | 2014-09-25 |
| Model Number | DIGITAL |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NUCLETRON |
| Manufacturer Address | WAARDGELDER 1 VEENENDAAL, NL |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-09-25 |