FRESENIUS DIALYSIS DELIVERY SYSTEM
Received Jan 11, 2002 · Event occurred Sep 25, 2001
Report 2937457-2002-00004 · MDR key 371736
Device
Generic name
Hemodialysis Machine
Manufacturer
Fresenius Medical Care-north AmericaModel number
2008KCatalog number
NA
Lot number
NA
Product problems
- Increase in Pressure
- Replace
- Insufficient Flow or Under Infusion
- Other (for use when an appropriate device code cannot be identified)
Patient
UNKNOWN
- Low Blood Pressure/ Hypotension
- Therapy/non-surgical treatment, aborted/stopped
- Treatment with medication(s)
- 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. REPORTS SUGGEST EXCESS FLUID WAS REMOVED DURING HEMODIALYSIS TREATMENTS. INFORMATION PROVIDED WAS VERY LIMITED. THERE WAS NO REPORTED SERIOUS INJURY. THE PATIENT BECAME HYPOTENSIVE 25 MINUTES AFTER TREATMENT WAS STARTED. THERE WAS LOW ARTERIAL PRESSURE, HIGH VENOUS PRESSURE AND HIGH TRANSMEMBRANE PRESSURE REPORTED DURING TREATMENT. "BLACK BLOOD" WAS OBSERVED. TREATMENT WAS RESUMED ON A DIFFERENT MACHINE. BASED ON THE REPORTED WEIGHTS, SALINE GIVEN AND WHAT THE MACHINE HAD INDICATED WAS REMOVED, THERE WAS A FLUID LOSS VARIANCE OF APPROXIMATLEY 2.6 KG. IT IS UNKNOWN IF PRESSURE HOLDING TEST WAS PERFORMED. ON-LINE PRESSURE HOLDING TEST WAS NOT ACTIVATED.