MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2009-11-08 for PRISMAFLEX * manufactured by Gambro Renal Products, Inc..
[16638986]
Continuous renal replacement therapy (crrt) hemofilter memory error code 6 alarm when attempting to adjust fluid removal rate. Self test alarmed. When self test completed patient fluid removal remained highlighted. However, at first attempt to continue to adjust fluid level, memory error 6 alarmed. Attempted to turn off/on and unplug filter, but filter still clotted. Staff unable to return blood to patient. Surgical critical care notified. A new filter obtained and crrt resumed.
Patient Sequence No: 1, Text Type: D, B5
[16701316]
Continuous renal replacement therapy (crrt) hemofilter memory error code 6 alarm when attempting to adjust fluid removal rate. Self test alarmed. When self test completed patient fluid removal remained highlighted. However, at first attempt to continue to adjust fluid level, memory error 6 alarmed. Attempted to turn off/on and unplug filter, but filter still clotted. Staff unable to return blood to patient. Surgical critical care notified. A new filter obtained and crrt resumed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1525996 |
| MDR Report Key | 1525996 |
| Date Received | 2009-11-08 |
| Date of Report | 2009-11-08 |
| Date of Event | 2009-10-28 |
| Report Date | 2009-11-08 |
| Date Reported to FDA | 2009-11-08 |
| Date Added to Maude | 2009-11-13 |
| 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 | PRISMAFLEX |
| Generic Name | HEMODIALYSIS, CONTINUOUS RENAL REPLACEMENT THERAPY |
| Product Code | MQS |
| Date Received | 2009-11-08 |
| Model Number | PRISMAFLEX |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | NURSE |
| Device Availability | Y |
| Device Age | 6 MO |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GAMBRO RENAL PRODUCTS, INC. |
| Manufacturer Address | VICE PRESIDENT REGULATORY AFFA 14143 DENVER WEST PARKWAY, SUI LAKEWOOD CO 80401 US 80401 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-11-08 |