MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-09-24 for EXTRACORPOREAL CUSTOM TUBING PACK N/A 7898 manufactured by Gish Biomedical.
[3766]
The report indicated that a patienet on a pediatric ecmo circuit expired after a failure in the custom ecmo circuit. Cause of death had not been indicated as of this date. Device labeled for single use. Patient medical status prior to event: critical condition. 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. Device used as labeled/intended. Invalid data - regarding evaluation by user after event. Method of evaluation: none or unknown. Results of evaluation: none or unknown. Conclusion: none or unknown. Certainty of device as cause of or contributor to event: unknown (cannot determine). Corrective actions: none or unknown. The device was not destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 34694-1993-00001 |
| MDR Report Key | 6832 |
| Date Received | 1993-09-24 |
| Date of Report | 1993-07-20 |
| Date of Event | 1993-07-06 |
| Date Facility Aware | 1993-07-07 |
| Report Date | 1993-07-20 |
| Date Reported to FDA | 1993-07-20 |
| Date Reported to Mfgr | 1993-07-07 |
| Date Added to Maude | 1993-10-21 |
| 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 | EXTRACORPOREAL CUSTOM TUBING PACK |
| Generic Name | CUSTOM TUBING PACK |
| Product Code | LLB |
| Date Received | 1993-09-24 |
| Model Number | N/A |
| Catalog Number | 7898 |
| Lot Number | 028307 |
| ID Number | N/A |
| Device Expiration Date | 1995-06-01 |
| Operator | OTHER |
| Device Availability | Y |
| Device Age | 01-MAR-93 |
| Implant Flag | N |
| Device Sequence No | 1 |
| Device Event Key | 6515 |
| Manufacturer | GISH BIOMEDICAL |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 1993-09-24 |