MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-05-22 for UNIFLOW 43-12N manufactured by Baxter.
[20057716]
The plastic lock on the transducer fractured/leaked and the pump filled the bed with blood. The patient had to be transfuseddevice not labeled for single use. Patient medical status prior to event: satisfactory condition. There was not multiple patient involvement. Device serviced in accordance with service schedule. Date last serviced:. Service provided by: invalid data. Invalid data - service records availability. No imminent hazard to public health claimed. Device used as labeled/intended. Device was evaluated after the event. Method of evaluation: visual examination. Results of evaluation: component failure, telemetry failure. Conclusion: invalid data. Certainty of device as cause of or contributor to event: invalid data. Corrective actions: no data. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 602 |
| MDR Report Key | 602 |
| Date Received | 1992-05-22 |
| Date of Report | 1992-05-06 |
| Date of Event | 1992-05-05 |
| Date Facility Aware | 1992-05-05 |
| Report Date | 1992-05-06 |
| Date Reported to FDA | 1992-05-06 |
| Date Reported to Mfgr | 1992-05-06 |
| Date Added to Maude | 1992-05-26 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNIFLOW |
| Generic Name | DISPOSABLE PRESSURE TRANDUCERS |
| Product Code | BXO |
| Date Received | 1992-05-22 |
| Model Number | 43-12N |
| Lot Number | 2B0183-SJ2B2748 |
| Device Expiration Date | 1994-03-01 |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | * |
| Device Sequence No | 1 |
| Device Event Key | 592 |
| Manufacturer | BAXTER |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1992-05-22 |