MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-01-18 for PRISMAFLEX * N/A manufactured by Gambro Renal Products, Inc..
[1413742]
While changing the effluent drainage bag, the computer screen on the prismaflex crrt (continuous renal replacement therapy) machine froze, causing a scale malfunction that shut off the blood pump. I was unable to restart the blood pump after attempting to "retest" the scale function several times. The patient lost approximately 200 cc's of blood remaining in the system. This filter had been up and running only 15 hours prior to this.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1595433 |
| MDR Report Key | 1595433 |
| Date Received | 2010-01-18 |
| Date of Report | 2010-01-18 |
| Date of Event | 2009-12-20 |
| Report Date | 2010-01-18 |
| Date Reported to FDA | 2010-01-18 |
| Date Added to Maude | 2010-02-05 |
| 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 |
| 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 | PRISMAFLEX |
| Generic Name | HEMODIALYSIS MACHINE, CONTINUOUS RENAL REPLACMENT THERAPY |
| Product Code | MQS |
| Date Received | 2010-01-18 |
| Model Number | * |
| Catalog Number | N/A |
| Lot Number | N/A |
| ID Number | * |
| Operator | NURSE |
| Device Availability | Y |
| Device Age | 8 MO |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GAMBRO RENAL PRODUCTS, INC. |
| Manufacturer Address | 14143 DENVER WEST PARKWAY, SUI LAKEWOOD CO 80401 US 80401 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-01-18 |