MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-02-08 for PRISMAFLEX 107493 N/A manufactured by Gambro Renal Products.
[22125170]
The effluent drain bag was changed on machine around midnight. Machine flips hour about 10 minutes after actual time. The operator went back to machine to get fluid removal volume and pressure readings from previous hour and noted effluent pressure to be zero (had been 50's). Monitor started alarming that patient's blood pressure was low. There were no alarms on crrt (continuous renal replacement therapy) machine. When checking history on machine it was noted that current hour fluid removal was already at 130 ml in the 6-8 minutes since the hour had flipped, and still no alarms on machine. The operator hit key for change bag, opened scale, and shut it again. Therapy was restarted and effluent pressure back to 40's. Patient's neosynephrine drip increased and gave patient 150 ml of 0. 9 normal saline. No alarms or issues with pressures through the rest of shift.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1618501 |
| MDR Report Key | 1618501 |
| Date Received | 2010-02-08 |
| Date of Report | 2010-02-08 |
| Date of Event | 2010-01-17 |
| Report Date | 2010-02-08 |
| Date Reported to FDA | 2010-02-08 |
| Date Added to Maude | 2010-03-02 |
| 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, CONTINUOUS RENAL REPLACE THERAPY |
| Product Code | MQS |
| Date Received | 2010-02-08 |
| Model Number | 107493 |
| Catalog Number | N/A |
| Lot Number | N/A |
| ID Number | * |
| Device Availability | Y |
| Device Age | 8 MO |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GAMBRO RENAL PRODUCTS |
| Manufacturer Address | 14143 DENVER WEST PARKWAY SUITE 400 LAKEWOOD CO 80401 US 80401 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-02-08 |