FRESENIUS DIALYSIS DELIVERY SYSTEM
Received Mar 6, 2002 · Event occurred Feb 15, 2002
Report 2937457-2002-00018 · MDR key 381382
Device
Generic name
Hemodialysis Machine
Manufacturer
Fresenius Medical Care North AmericaModel number
2008KCatalog number
NA
Lot number
NA
Product problems
- Replace
- Insufficient Flow or Under Infusion
Patient
UNKNOWN
- Low Blood Pressure/ Hypotension
- Therapy/non-surgical treatment, aborted/stopped
- Treatment with medication(s)
- Weight Changes
Narrative
Description of Event or Problem
FRESENIUS MEDICAL CARE CANADA, INC. REPORTED THAT THERE WAS EXCESS FLUID REMOVED FROM A PATIENT DURING A HEMODIALYSIS TREATMENT. THE PATIENT BECAME HYPOTENSIVE 30 MIN. INTO THE TREATMENT. BLOOD IN THE EXTRACORPOREAL CIRCUIT WAS NOTED TO BE DARK. THE PATIENT WAS GIVEN SALINE AND WAS WEIGHED AT THIS TIME. BASED ON THE REPORTED WEIGHTS AND WHAT THE MACHINE INDICATED WAS REMOVED, THERE WAS A WEIGHT LOSS VARIANCE OF APPROX 2.7 KG. TREATMENT WAS CONTINUED ON ANOTHER MACHINE WITH NO FURTHER PROBLEM. THERE WAS NO SERIOUS INJURY OR ILLNESS.