MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-01-04 for PRIXMA FLO II manufactured by Baxter (formerly Gambro).
[96618131]
Crrt prisma pump (prisma flo ii) was in recirculation for approx 2 hrs; rn went to put pt back on the circuit when noticed a burning smell to the room. Prisma pump blood heater tubing was smoking and actively burning hole through sheets and mattress of pt's bed at the foot of the bed. Crrt machine was immediately turned off and taken out of pt's room, ensured pt was safe from harm and room free of smoke damage, fire alarm activated. Pt unharmed during event and remained in current room after pt was placed on new bed. Both crrt machine as well as bed that was damaged were quarantined.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5074427 |
| MDR Report Key | 7168791 |
| Date Received | 2018-01-04 |
| Date of Report | 2018-01-03 |
| Date of Event | 2018-01-01 |
| Date Added to Maude | 2018-01-05 |
| 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 | 3 |
| Reporter Occupation | ATTORNEY |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | PRIXMA FLO II |
| Generic Name | BLOOD WARMER |
| Product Code | MDP |
| Date Received | 2018-01-04 |
| Lot Number | GHNA02497 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BAXTER (FORMERLY GAMBRO) |
| Manufacturer Address | US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-01-04 |