MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-01-06 for PRISMA manufactured by Gambro Renal Products, Inc..
[35159359]
Patient Sequence No: 1, Text Type: N, H10
[35159360]
Multiple incorrect dialysate weight change alarms in a 24 hour period (same patient).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5346394 |
| MDR Report Key | 5346394 |
| Date Received | 2016-01-06 |
| Date of Report | 2015-12-11 |
| Date of Event | 2007-04-11 |
| Report Date | 2015-12-11 |
| Date Reported to FDA | 2015-12-11 |
| Date Reported to Mfgr | 2015-12-11 |
| Date Added to Maude | 2016-01-06 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PRISMA |
| Generic Name | DIALYSIS MACHINE |
| Product Code | ONW |
| Date Received | 2016-01-06 |
| Operator | NURSE |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GAMBRO RENAL PRODUCTS, INC. |
| Manufacturer Address | 9540 MAROON CIR FL 4 ENGLEWOOD, CO 80112 US 80112 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-01-06 |