MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2006-03-30 for PRISMA CONTROL UNIT 018080001D manufactured by Gambro Dasco.
[477579]
Facility biomedical technician reported a blood pump malfunctionand effluent pressure pod alarms (0080), and increased clotting alarms. He stated that the nurses had gone though 10 prisma hemofilter sets. He explained that during the 2 hour self test, the machine would fail due to an effluent pressure pod (0080) which consistently happened for 10 hours. The prisma hemofilter set was clotting during treatment and the effluent bag emptied within 1 hour. The patient treatment was then discontinued and reinitiated on another machine without any problems.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2087532-2006-00047 |
| MDR Report Key | 694621 |
| Date Received | 2006-03-30 |
| Date of Report | 2006-02-28 |
| Date of Event | 2006-02-27 |
| Date Facility Aware | 2006-02-28 |
| Report Date | 2006-02-28 |
| Date Reported to Mfgr | 2006-02-28 |
| Date Added to Maude | 2006-04-04 |
| 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 | 3 |
| 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 | PRISMA CONTROL UNIT |
| Generic Name | INTENSIVE CARE HEMODIALYSIS |
| Product Code | FIF |
| Date Received | 2006-03-30 |
| Model Number | PRISMA |
| Catalog Number | 018080001D |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 3 YR |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 683750 |
| Manufacturer | GAMBRO DASCO |
| Manufacturer Address | VIA MODENESE, 66 MEDOLLA (MO) IT I-41036 |
| Baseline Brand Name | PRISMA CONTROL UNIT |
| Baseline Generic Name | INTENSIVE CARE HEMODIALYSIS |
| Baseline Model No | PRISMA |
| Baseline Catalog No | 018080100 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2006-03-30 |