MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2009-09-01 for THERMOCHEM HT-1000 * manufactured by Thermasolutions.
[1132871]
Thermocare machine was being used with a hipec (heated intraoperative intraperitoneal chemotherapy) case. The perfusionist said the screen froze. Temperature regulation via the machine was disabled and manual temperature regulation measures were used to proceed with the case. There was no effect/injury to the patient. Our biomed department did not assess the device as it was returned to the manufacturer's representative immediately after the case. (this is not our procedure and that has been addressed at our level). Biomed reports that this is the third time in four cases that we have had problems with an ht-1000 from thermasolutions. All the occurrences indicate screen issues. However, there are no other similar devices available per biomed department.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1478197 |
| MDR Report Key | 1478197 |
| Date Received | 2009-09-01 |
| Date of Report | 2009-09-01 |
| Date of Event | 2009-08-17 |
| Report Date | 2009-09-01 |
| Date Reported to FDA | 2009-09-01 |
| Date Added to Maude | 2009-09-22 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | THERMOCHEM |
| Generic Name | INTRAPERITONEAL HYPERTHERMIA SYSTEM |
| Product Code | MLW |
| Date Received | 2009-09-01 |
| Returned To Mfg | 2009-08-17 |
| Model Number | HT-1000 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | THERMASOLUTIONS |
| Manufacturer Address | 1889 BUERKLE ROAD WHITE BEAR LAKE MN 55110 US 55110 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-09-01 |