FRESENIUS DIALYSIS DELIVERY SYSTEM
Received Jan 11, 2002 · Event occurred Dec 5, 2001
Report 2937457-2002-00005 · MDR key 371726
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
Patient
UNKNOWN
- Low Blood Pressure/ Hypotension
- Blood pressure, low
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. REPORTS SUGGEST EXCESS FLUID WAS REMOVED DURING HEMODIALYSIS TREATMENTS. INFORMATION PROVIDED WAS VERY LIMITED. THERE WAS NO REPORTED SERIOUS INJURY. THE PATIENT HAD LOW BLOOD PRESSURE AFTER ONE HOUR. REPORTED ULTRAFILTRATE REMOVED WAS 1.8 KG IN ONE HOUR. THE MACHINE SHOWED THAT 0.4 KG. WAS REMOVED. PRESSURE HOLDING TEST WAS PERFORMED AND PASSED. ON-LINE PRESSURE HOLDING TEST WAS NOT ACTIVATED.