MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-11-07 for HOWES LARGE BORE MULTI-LUMEN CENTRAL VEIN CATHETERIZATION KT AK-12123-H manufactured by Arrow International, Inc..
[10208]
Trialysis catheters were inserted bilaterally into femoral veins. These catheters were connected to a cavh filter. After beginning the cavh, the nurse noticed a slight blood leak at the trialysis limb adapter connection. Cavh was stopped, a medical resident came down, cut off the end of the limb of the catheter and attached a new adapter from another trialysis kit. This corrected the problem, however, the cavh filter could not be salvaged. Before a new cavh filter could be primed, the pt arrested and subsequently died despite resuscitation attempts. This pt was in critical condition with multisystem failure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1003920 |
| MDR Report Key | 17449 |
| Date Received | 1994-11-07 |
| Date of Report | 1994-10-31 |
| Date of Event | 1994-10-21 |
| Date Added to Maude | 1994-11-08 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HOWES LARGE BORE MULTI-LUMEN CENTRAL VEIN CATHETERIZATION KT |
| Product Code | LFK |
| Date Received | 1994-11-07 |
| Catalog Number | AK-12123-H |
| Lot Number | AK-1-234-4 |
| Device Availability | N |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 17377 |
| Manufacturer | ARROW INTERNATIONAL, INC. |
| Manufacturer Address | READING PA 19605 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1994-11-07 |