MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-06-11 for PASZ PULSATILE ANTI EMBOLISM SYSTEM 35E10000 AND 35E0000 AIR PUMP SAME AS MODEL NUMBER manufactured by Baxter Healthcare Corporatioln - Pharmaseal Division.
[3530]
At the conclusion of the surgical procedure, it was noticed that the equipment was malfunctioningdevice not labeled for single use. Patient medical status prior to event: satisfactory condition. There was not multiple patient involvement. Device not serviced in accordance with service schedule. Date last serviced: 01-jun-92. Service provided by: user facility biomedical/bioengineering department. Service records available. No imminent hazard to public health claimed. Device used as labeled/intended. Device was evaluated after the event. Method of evaluation: actual device involved in incident was evaluated, mechanical tests performed, performance tests performed, visual examination. Results of evaluation: invalid data. Conclusion: device failure occurred and was related to event, device failure directly caused event. Certainty of device as cause of or contributor to event: invalid data. Corrective actions: device permanently removed from service. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 4976 |
| MDR Report Key | 4976 |
| Date Received | 1993-06-11 |
| Date of Report | 1993-04-28 |
| Date of Event | 1993-01-29 |
| Date Facility Aware | 1993-01-29 |
| Report Date | 1993-04-28 |
| Date Reported to Mfgr | 1993-01-29 |
| Date Added to Maude | 1993-06-22 |
| 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 | 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 | PASZ PULSATILE ANTI EMBOLISM SYSTEM |
| Product Code | CBA |
| Date Received | 1993-06-11 |
| Model Number | 35E10000 AND 35E0000 AIR PUMP |
| Catalog Number | SAME AS MODEL NUMBER |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | Y |
| Device Age | 01-JAN-92 |
| Implant Flag | N |
| Device Sequence No | 1 |
| Device Event Key | 4679 |
| Manufacturer | BAXTER HEALTHCARE CORPORATIOLN - PHARMASEAL DIVISION |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1993-06-11 |