InjuryFIL
FRESENIUS DIALYSIS DELIVERY SYSTEM
Received Oct 19, 2006 · Event occurred Sep 20, 2006
Report 2937457-2006-00010 · MDR key 772351
Device
Generic name
Hemodialysis Machine
Manufacturer
Fresenius Medical Care North AmericaModel number
2008KCatalog number
NA
Lot number
NA
Product problems
- Alarm, audible
- Complete Blockage
- Other (for use when an appropriate device code cannot be identified)
Patient
4 YR
- Transfusion of blood products
- Blood Loss
Narrative
Description of Event or Problem
A DIALYSIS FACILITY REPORTED THAT THERE WERE FREQUENT TMP ALARMS DURING A HEMODIALYSIS TREATMENT. BLOOD IN THE EXTRACORPOREAL CIRCUIT CLOTTED SINCE THEY WERE UNABLE TO CLEAR THE ALARMS. BLOOD LOSS WAS <100 CC. AND THE PT WAS TRANSFUSED WITH 30 CC. OF PACKED RED BLOOD CELLS.