MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-04-20 for HAEMOCELL SYSTEM 350 216-350-110 N/A manufactured by Haemocell Plc.
[3373]
It is alleged that the device ceased to function during use, disallowing the reinfusion of 500cc of a patient's autologous blood. No injury was reported. Device not labeled for single use. Patient medical status prior to event: invalid data. There was not multiple patient involvement. Invalid data - on device service/maintenance. No data - regarding date last serviced. Service provided by: invalid data. Invalid data - service records availability. No imminent hazard to public health claimed. Invalid data - whether device used as labeled/intended. Device was not evaluated after the event. Method of evaluation: no data. Results of evaluation: no data. Conclusion: no data. Certainty of device as cause of or contributor to event: invalid data. Corrective actions: none or unknown. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1811755-1993-00002 |
| MDR Report Key | 5327 |
| Date Received | 1993-04-20 |
| Date of Report | 1993-02-23 |
| Date of Event | 1993-02-02 |
| Report Date | 1993-02-23 |
| Date Reported to Mfgr | 1993-02-02 |
| Date Added to Maude | 1993-07-08 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | UNKNOWN |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HAEMOCELL SYSTEM 350 |
| Generic Name | AUTOLOGOUS BLOOD PROCESSING SYSTEM |
| Product Code | KSW |
| Date Received | 1993-04-20 |
| Model Number | 216-350-110 |
| Catalog Number | N/A |
| Lot Number | N/A |
| ID Number | N/A |
| Operator | OTHER |
| Device Availability | Y |
| Implant Flag | N |
| Device Sequence No | 1 |
| Device Event Key | 5024 |
| Manufacturer | HAEMOCELL PLC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1993-04-20 |