FDA Adverse Event
Summary report: N
PRISMA
MDR report key: 1025944
·
Received March 6, 2008
Report
- Report Number
- 1025944
- Date Received
- March 6, 2008
- Date of Event
- August 11, 2007
- Report Date
- March 6, 2008
- Manufacturer
- GAMBRO RENAL PRODUCTS, INC.
- Product Code
- KDI
- Report Source
- User Facility report
- Reporter Location
- TX, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
SELF TEST FAILURE AND ALARMING FILTER CLOTTING, AND TMP HIGH EFFLUENT PRESSURE 150-160.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PRISMA | DIALYSIS MACHINE | KDI | GAMBRO RENAL PRODUCTS, INC. | PRISMA | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 13 YR |