FRESENIUS DIALYSIS DELIVERY SYSTEM
Received Jan 2, 2008 · Event occurred Dec 5, 2007
Report 2937457-2008-00001 · MDR key 973522
Device
Generic name
Hemodialysis Machine
Manufacturer
Fresenius Medical Care North AmericaModel number
2008KCatalog number
NA
Lot number
NA
Product problems
- Increase in Pressure
Patient
57 YR
- Low Blood Pressure/ Hypotension
- Dizziness
- Hospitalization required
Narrative
Description of Event or Problem
A DIALYSIS FACILITY REPORTED, THAT A PATIENT C/O DIZZINESS AND BECAME HYPOTENSIVE ONE HOUR INTO A HEMODIALYSIS TREATMENT WAS GIVEN ONE LITER OF SALINE. SHE CONTINUED TO BE HYPOTENSIVE AND UNSTABLE EVEN AFTER RECEIVING AN ADDITIONAL 800 ML. OF SALINE. SHE WAS TAKEN TO THE HOSPITAL AND WAS ADMITTED FOR UNSTABLE HYPOTENSION. THE TRANSMEMBRANE PRESSURE INCREASED FROM 40 TO 120 DURING TREATMENT. THERE WAS NO OTHER MACHINE PROBLEM NOTED. THE PATIENT'S WEIGHT WAS 2 KG. BELOW HER DRY WEIGHT AFTER RECEIVING 1.8 LITERS OF SALINE.
Additional Manufacturer Narrative
DEVICE INVESTIGATION PERFORMED BY A FRESENIUS EQUIPMENT SPECIALIST SHOWED A UF COUNTER ERROR OF 21 ML (MAXIMUM ALLOWABLE IS 10 ML). THE FUNCTIONAL BOARD WAS REPLACED FOR THIS PROBLEM. THE EXCESS UF WAS NOT DUPLICATED.