MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-03-07 for DOUBLE LUMEN CATHETER manufactured by Kendall Healthcare Products, Inc..
[4406]
Post membrane ecmo pump pressure greater than 600 mm hg. Visual exam revealed no obvious problems. Device returned to manufacturer for evaluation. 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. Device was evaluated after the event. Method of evaluation: actual device involved in incident was evaluated, visual examination. Results of evaluation: none or unknown. Conclusion: device evaluated and alleged failure could not be duplicated. Certainty of device as cause of or contributor to event: maybe. 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 | 7935 |
| MDR Report Key | 7935 |
| Date Received | 1994-03-07 |
| Date of Report | 1993-12-30 |
| Date of Event | 1993-11-13 |
| Date Facility Aware | 1993-11-13 |
| Report Date | 1993-12-30 |
| Date Reported to Mfgr | 1993-12-30 |
| Date Added to Maude | 1994-06-07 |
| 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 |
| Generic Name | DOUBLE LUMEN CATHETER |
| Product Code | GBP |
| Date Received | 1994-03-07 |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Device Sequence No | 1 |
| Device Event Key | 7611 |
| Manufacturer | KENDALL HEALTHCARE PRODUCTS, INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1994-03-07 |