FRESENIUS DIALYSIS DELIVERY SYSTEM
Received Jan 11, 2002 · Event occurred Dec 19, 2001
Report 2937457-2002-00007 · MDR key 371748
Device
Generic name
Hemodialysis Machine
Manufacturer
Fresenius Medical Care-north AmericaModel number
2008KCatalog number
NA
Lot number
NA
Product problems
- Insufficient Flow or Under Infusion
- Other (for use when an appropriate device code cannot be identified)
Patient
UNKNOWN
- Low Blood Pressure/ Hypotension
- Other (for use when an appropriate patient code cannot be identified)
- Weight Changes
Narrative
Description of Event or Problem
REPORTS OF ULTRAFILTRATION PROBLEMS THAT WERE OBSERVED OVER SEVERAL MONTHS WERE RECEIVED FROM THE MANUFACTURER'S AFFILIATE IN CANADA ON 12/14/2001 AND ON 01/03/2002. REPORTS SUGGEST EXCESS FLUID WAS REMOVED DURING HEMODIALYSIS TREATMENTS. INFORMATION PROVIDED WAS VERY LIMITED. THERE WAS NO REPORTED SERIOUS INJURY. THE PATIENT BECAME HYPOTENSIVE 27 MINUTES INTO THE TREATMENT. "BLACK BLOOD" WAS REPORTEDLY OBSERVED. THE PATIENT'S POST WEIGHT INDICATED A WEIGHT LOSS OF 1.7 KG. THE MACHINE SHOWED THAT 397 ML. WAS REMOVED. PRESSURE HOLDING TEST WAS NOT PERFORMED AND ON-LINE PRESSURE HOLDING TEST WAS NOT ACTIVATED.