MalfunctionFII
*
Received May 15, 2013 · Event occurred May 9, 2013
Report 3115213 · MDR key 3115213
Device
Product problems
- Device Inoperable
Patient
46 YR
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
APPROXIMATELY 30 MINUTES INTO DIALYSIS TREATMENT, BLOOD PUMP ON PATIENT'S MACHINE STOPPED WORKING. ALL BLOOD RE-INFUSED AND PATIENT MOVED TO ANOTHER MACHINE WHERE DIALYSIS WAS RESUMED WITHOUT INCIDENT. FRESENSIUS MEDICAL CARE CONTACTED.WORK ORDER PLACED WITH FRESENIUS TO FIX MACHINE.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.