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..
[17018370]
Prisma citrate bags were bone dry. The system did not alarm. The system took in air, and machine stated "system failure in need of maintenance"... Enough air was in line that machine shut down. The prismaflex dialysis machine went down and this could have been a potential disaster. Risk management was made aware. The machine continued to infuse air, the alarm did not go off, and the message came up for "system failure". The citrate bag line sucked in air--there was so much air that they could not recirculate blood. I inquired on the patient status and was informed that this has happened to this patient with this machine before. She can be off dialysis for a short time. This machine goes down after 18-30 hours for this patient. Earlier in the day they had a back up machine, but that was used for another patient and the hospital does not have any other machines available.
Patient Sequence No: 1, Text Type: D, B5
[17059459]
Prisma citrate bags were bone dry. The system did not alarm. The system took in air, and machine stated "system failure in need of maintenance"... Enough air was in line that machine shut down. The prismaflex dialysis machine went down and this could have been a potential disaster. Risk management was made aware. The machine continued to infuse air, the alarm did not go off, and the message came up for "system failure". The citrate bag line sucked in air--there was so much air that they could not recirculate blood. I inquired on the patient status and was informed that this has happened to this patient with this machine before. She can be off dialysis for a short time. This machine goes down after 18-30 hours for this patient. Earlier in the day they had a back up machine, but that was used for another patient and the hospital does not have any other machines available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1525971 |
| MDR Report Key | 1525971 |
| Date Received | 2009-11-08 |
| Date of Report | 2009-11-08 |
| Date of Event | 2009-11-01 |
| 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 80215 US 80215 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-11-08 |