MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2002-03-19 for BLOOD MONITOR PUMP BM11A * manufactured by Baxter Healthcare Corp.
[281342]
Pt admitted in 2002 for altered mental status and hypotension. K+ 2. 9 on admission. New onset cyanosis toes left foot. Md ordered hemofiltration due to pt's condition. Hemofiltration unit arterial pressure line alarming. The next day unit checked. Recalibrated. Still showing error. Baxter support contacted. New transducers ordered. The next day replaced transducers. Still problem with arterial pressure. Baxter support contacted multiple times. The next day replaced transducer pcb. Error still present. Service rep in reportedly fixed unit. Unit in use on pt four days later. Intermittently functioning but circuit clotting off. At 0400 resumed hemofiltration, pt condition deteriorated expired 0555.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 384303 |
| MDR Report Key | 384303 |
| Date Received | 2002-03-19 |
| Date of Report | 2002-03-14 |
| Date of Event | 2002-03-01 |
| Date Facility Aware | 2002-03-01 |
| Report Date | 2002-03-14 |
| Date Reported to FDA | 2002-03-14 |
| Date Added to Maude | 2002-03-27 |
| 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 | BLOOD MONITOR PUMP |
| Generic Name | HEMOFILTRATION UNIT |
| Product Code | FIR |
| Date Received | 2002-03-19 |
| Model Number | BM11A |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 2.5 YR |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 373355 |
| Manufacturer | BAXTER HEALTHCARE CORP |
| Manufacturer Address | PO BOX 1230 PINELLAS PARK FL 337801230 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2002-03-19 |