FRESENIUS DIALYSIS DELIVERY SYSTEM
Received May 13, 2008 · Event occurred Apr 14, 2008
Report 2937457-2008-00004 · MDR key 1046977
Device
Generic name
Hemodialysis Machine
Manufacturer
Fresenius Medical Care-north AmericaModel number
2008KCatalog number
NA
Lot number
NA
Product problems
- Unknown (for use when the device problem is not known)
Patient
47 YR
- Low Blood Pressure/ Hypotension
Narrative
Description of Event or Problem
A DIALYSIS FACILITY REPORTED THAT A PATIENT BECAME HYPOTENSIVE AFTER A HEMODIALYSIS TREATMENT AND PASSED OUT IN THE PARKING LOT. THERE WAS NO REPORTED DEVICE PROBLEM DURING TREATMENT. BASED ON THE REPORTED PRE AND POST WEIGHTS, SALINE GIVEN AND WHAT THE MACHINE INDICATED WAS REMOVED, THERE WAS A FLUID WEIGHT LOSS VARIANCE OF 1.5 KG. PATIENT RECOVERED WITHOUT INJURY.
Additional Manufacturer Narrative
DEVICE INVESTIGATION WAS PERFORMED BY THE FACILITY BIO-MED. THERE WAS AN ULTRAFILTRATION (UF) ERROR OF 48 ML/HR. BUT THIS DOES NOT ACCOUNT FOR THE HIGH UF FOR THIS EVENT.