MalfunctionFIL
FRESENIUS DIALYSIS DELIVERY SYSTEM
Received Mar 31, 2006 · Event occurred Mar 1, 2006
Report 2937457-2006-00003 · MDR key 695517
Device
Generic name
Hemodialysis Machine
Manufacturer
Fresenius Medical Care-north AmericaModel number
2008KCatalog number
NA
Lot number
NA
Patient
4 MO
Narrative
Description of Event or Problem
DURING A HEMODIALYSIS TREATMENT, THE NURSE NOTED THAT THE UF TIME WAS NOT COUNTING DOWN. THE TREATMENT WAS SET FOR A FLUID REMOVAL OF 30 ML. FOR ONE HOUR. BLOOD FLOW RATE WAS SET AT 10 ML/HR. WITH A 2.6 MM ID NEONATAL BLOODLINE. THE UF RATE WAS NOTED TO BE 70 ML/HR. INSTEAD OF 30 ML/HR. THE PT BECAME HYPOTENSIVE AND WAS GIVEN SALINE. TOTAL FLUID REMOVED AT THE END OF TREATMENT WAS 52 ML. THE NURSE CLAIMED THAT THE MACHINE WAS SET FROM PEDIATRIC MODE.