FDA Adverse Event
Malfunction
Summary report: N
FRESENIUS DIALYSIS DELIVERY SYSTEM
MDR report key: 378038
·
Received February 15, 2002
Report
- Report Number
- 2937457-2002-00012
- Event Type
- Malfunction
- Date Received
- February 15, 2002
- Date of Event
- December 22, 2001
- Report Date
- January 22, 2002
- Manufacturer
- FRESENIUS MEDICAL CARE-NORTH AMERICA
- Product Code
- FIL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
FRESENIUS MEDICAL CARE CANADA, INC. REPORTED THAT THERE WAS EXCESSIVE FLUID REMOVED DURING A HEMODIALYSIS TREATMENT. THE PATIENT BECAME HYPOTENSIVE AND C/O CRAMPS 13 MINUTES BEFORE THE END OF TREATMENT AND RECEIVED A LITER OF SALINE. BASED ON THE PRE AND POST WEIGHTS REPORTED, SALINE GIVEN AND WHAT THE MACHINE INDICATED WAS REMOVED, THERE WAS A WEIGHT LOSS VARIANCE OF APPROXIMATELY 2.5 KG. THERE WAS NO SERIOUS INJURY OR ILLNESS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FRESENIUS DIALYSIS DELIVERY SYSTEM | HEMODIALYSIS MACHINE | FIL | FRESENIUS MEDICAL CARE-NORTH AMERICA | 2008K | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN |