FDA Adverse Event
Death
Summary report: N
PRISMA CONTROL UNIT
MDR report key: 568085
·
Received January 27, 2005
Report
- Report Number
- 9616240-2005-00001
- Event Type
- Death
- Date Received
- January 27, 2005
- Date of Event
- December 31, 2004
- Report Date
- January 3, 2005
- Manufacturer
- GAMBRO DASCO
- Product Code
- KDI
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT ON A PT THE PRISMA MACHINE WAS SET AT 50-ML/HOUR PATIENT FLUID REMOVAL RATE BUT REMOVED 181 ML IN ONE HOUR. THEN, THE PT FLUID REMOVAL RATE WAS SET TO 0 ML/HOUR BUT WITHIN 1/2 HOUR ANOTHER 115 ML WERE REMOVED. IT WAS PERFORMED CONTINUOUS VENO-VENOUS HEMODIAFILTRATION (CVVHDF) TREATMENT AND PRISMA M60 SET WAS USED. ACCORDING TO THE NURSE, THEY RETURNED THE BLOOD AND GAVE FLUIDS BECAUSE OF THE DROP IN PRESSURE. FURTHER INFO REVEALED THAT THE PATIENT DIED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PRISMA CONTROL UNIT | INTENSIVE CARE HEMODIALYSIS | KDI | GAMBRO DASCO | PRISMA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Death| O |