MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-12 for CAPITAL TEMP PUMP PROFESSIONAL TP700 manufactured by Stryker Medical-kalamazoo.
[123677217]
The following event was reported via user facility medwatch (b)(4): it was reported that a patient has 2 one centimeter burn wounds presumed to be from the heating pad. One wound is healed and the second is being treated by the wound team.
Patient Sequence No: 1, Text Type: D, B5
[134207112]
Attempts were made to contact the user facility to gather further information regarding this alleged issue, however, the customer did not respond to these attempts. A review of device functionality and a conversation with a stryker clinical nurse consultant identified that for a burn to occur, the product would need to be greater than 44 degrees celsius. Without a failure of the backup and primary thermostats, the highest temperature the t-pump can reach is 42 degrees celsius. As such, this issue could not have occurred without a failure of both the primary and backup limit thermostats. This could not be confirmed. Device not returned.
Patient Sequence No: 1, Text Type: N, H10
[134207113]
The following event was reported via user facility medwatch (b)(4): it was reported that a patient has 2 one centimeter burn wounds presumed to be from the heating pad. One wound is healed and the second is being treated by the wound team.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001831750-2018-01092 |
| MDR Report Key | 7962627 |
| Date Received | 2018-10-12 |
| Date of Report | 2019-01-10 |
| Date of Event | 2018-08-01 |
| Date Mfgr Received | 2018-09-17 |
| Date Added to Maude | 2018-10-12 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. BRIAN THOMPSON |
| Manufacturer Street | 3800 EAST CENTRE AVENUE |
| Manufacturer City | PORTAGE MI 49002 |
| Manufacturer Country | US |
| Manufacturer Postal | 49002 |
| Manufacturer Phone | 2693292100 |
| Manufacturer G1 | STRYKER MEDICAL-KALAMAZOO |
| Manufacturer Street | 3800 EAST CENTRE AVENUE |
| Manufacturer City | PORTAGE MI 49002 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 49002 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | CAPITAL TEMP PUMP PROFESSIONAL |
| Generic Name | PACK, HOT OR COLD, WATER CIRCULATING |
| Product Code | ILO |
| Date Received | 2018-10-12 |
| Catalog Number | TP700 |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER MEDICAL-KALAMAZOO |
| Manufacturer Address | 3800 EAST CENTRE AVENUE PORTAGE MI 49002 US 49002 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-10-12 |