MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 1996-12-11 for GAYMAR T-PUMP TP200 manufactured by Gaymar Industries, Inc..
[36111]
The pt has iv infiltrate into left hand on 5/23/96 resulting in extravasation of mannitol into hand tissues. The pt had pre-existing left arm edema. A heating pad was applied to hand. Exact length of use not known. Three days later blisters noted on left hand. Pt required full thickness skin graft on 7/26/96. Surgeon assessed burn to be thermal in nature. This report was rec'd by the mfr 26 august 1996 along with a letter stating the hosp was not certain of which pump was involved in the incident. It was also stated that the hosp would noify the mfr of the biomedical engineering eval of all pumps. Co has not rec'd that eval, but co will continue efforts to obtain the results. 12/10/96, staff from hosp stated during phone conversation with 2 staff from co, that eval of temperature therapy pumps would not be complete until end of 2/97. 12/10/96, hosp center ask if at this time she could confirm identity of complaint pump. She said, "although they don't know the serial number of the pump and they do own another co's pumps, the nurse involved was sure the incident pump was co tp200", which resolved initial confusion during the 8/26/96 discussion whether the pump involved was believed to be another co's or a co product. Blistering as a result of the procedure reported in the incident can occur in the absence of heat. At this time we have no indication that the product malfunctioned or that the device caused or contributed to the injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1313850-1996-00031 |
| MDR Report Key | 55583 |
| Report Source | 06 |
| Date Received | 1996-12-11 |
| Date of Report | 1996-12-10 |
| Date of Event | 1996-05-23 |
| Date Mfgr Received | 1996-08-26 |
| Date Added to Maude | 1996-12-17 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GAYMAR T-PUMP |
| Generic Name | TEMPERATURE THERAPY PUMP |
| Product Code | FOH |
| Date Received | 1996-12-11 |
| Model Number | TP200 |
| Catalog Number | TP200 |
| Lot Number | UNK |
| ID Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | NA |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 56119 |
| Manufacturer | GAYMAR INDUSTRIES, INC. |
| Manufacturer Address | 10 CENTRE DRIVE ORCHARD PARK NY 14127 US |
| Baseline Brand Name | TP200 TEMP PUMP |
| Baseline Generic Name | TEMPERATURE THERAPY PUMP |
| Baseline Model No | TP200 |
| Baseline Catalog No | TP200 |
| Baseline ID | * |
| Baseline Device Family | TEMPERATURE THERAPY PUMP |
| Baseline Shelf Life Contained | A |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | Y |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1996-12-11 |