DeathFII
FRESENIUS DIALYSIS DELIVERY SYSTEM
Received Mar 20, 2007
Report 2937457-2007-00004 · MDR key 834536
Device
Generic name
Hemodialysis Machine
Manufacturer
Fresenius Medical Care North AmericaModel number
UNKCatalog number
NA
Lot number
NA
Product problems
- Device Alarm System
- Disconnection
- Source, detachment from
Patient
Not reported
- Cardiac Arrest
- Death
- Exsanguination
- Extravasation
- Renal Disease, End Stage
Narrative
Additional Manufacturer Narrative
(OTHER) ADDITIONAL INFO WAS REQUESTED BUT NO FURTHER DETAILS REGARDING THE EVENT OR DEVICE INVESTIGATION WAS PROVIDED BY THE CONTACT PERSON. MANUFACTURER MAKES NO CLAIM THAT THE MACHINE WILL ALARM DURING THIS EVENT. THE OPERATOR'S MANUAL INCLUDES A WARNING STATING THAT THE PRESSURE CHANGES RESULTING FORM A LINE SEPARATION OR NEEDLE REMOVAL MAY BE TOO SMALL FOR THE SYSTEM TO DETECT AND THAT ALL CONNECTIONS MUST BE PROPERLY SECURED AND CHECKED REGULARLY.