DeathFII
FRESENIUS DIALYSIS DELIVERY SYSTEM
Received Apr 26, 2012 · Event occurred Mar 14, 2012
Report 2937457-2012-00017 · MDR key 2555996
Device
Generic name
Hemodialysis Machine
Manufacturer
Fresenius Medical Care North AmericaModel number
2008KCatalog number
NA
Lot number
NA
Product problems
- No Audible Alarm
Patient
UNK
- Death
Narrative
Description of Event or Problem
IT WAS REPORTED TO FRESENIUS MEDICAL CARE THAT A PT EXPIRED ABOUT ONE HOUR INTO A HEMODIALYSIS TREATMENT, INVESTIGATION IS ON-GOING.
Additional Manufacturer Narrative
SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON RECEIPT OF ADDITIONAL INFO. MFR COMPLAINT (B)(4).
Remedial action
- Other