MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1999-09-30 for BAXTER 9 FRENCH MULTILUMEN CATHETER M3L 9FHK1 * manufactured by Baxter Healthcare Corp..
[158561]
Pt with 9 french multilumen catheter placed during heart surgery experienced a neurological event during rewiring of the catheter postoperatively. Ct scan showed a thrombus in the right internal carotid artery which was treated with intra-arterial t-pa. Despite aggressive therapy, the pt experienced progressive left brain swelling and eventually slipped into a coma and died. The family refused autopsy. The co was notified immediately.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 242803 |
MDR Report Key | 242803 |
Date Received | 1999-09-30 |
Date of Report | 1999-09-27 |
Date of Event | 1999-08-24 |
Date Facility Aware | 1999-08-24 |
Report Date | 1999-09-27 |
Date Reported to FDA | 1999-09-27 |
Date Reported to Mfgr | 1999-09-27 |
Date Added to Maude | 1999-10-05 |
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 |
Reporter Occupation | RISK MANAGER |
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 | BAXTER 9 FRENCH MULTILUMEN CATHETER |
Generic Name | CATHETER |
Product Code | JCY |
Date Received | 1999-09-30 |
Model Number | M3L 9FHK1 |
Catalog Number | * |
Lot Number | * |
ID Number | * |
Operator | HEALTH PROFESSIONAL |
Device Availability | N |
Device Age | * |
Implant Flag | N |
Date Removed | * |
Device Sequence No | 1 |
Device Event Key | 235232 |
Manufacturer | BAXTER HEALTHCARE CORP. |
Manufacturer Address | ONE BAXTER PKWY DEERFIELD IL 600154633 US |
Baseline Brand Name | ADVANCED VENOUS ACCESS (AVA) CATHETER |
Baseline Generic Name | CENTRAL VENOUS ACCESS CATHETER |
Baseline Model No | M3L9FHKI |
Baseline Catalog No | NA |
Baseline ID | NA |
Baseline Shelf Life Contained | Y |
Baseline Shelf Life [Months] | 18 |
Baseline PMA Flag | N |
Baseline 510K PMN | Y |
Premarket Notification | K981909 |
Baseline Preamendment | N |
Baseline Transitional | N |
510k Exempt | N |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 1. Death | 1999-09-30 |