MalfunctionGKT
COBE SPECTRA WHITE BLOOD CELL SET
Received May 15, 2015 · Event occurred May 13, 2015
Report 4794446 · MDR key 4794446
Device
Generic name
Separator, Automated, Blood Cell, Diagnostic
Manufacturer
Terumo Bct, Inc.Model number
*Catalog number
NOT PROVIDED
Lot number
NOT PROVIDED
Product problems
- Device Displays Incorrect Message
Patient
*
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
WHILE PRIMING THE WHITE BLOOD CELL SET ON THE COPE APHERESIS MACHINE, THE MACHINE ALARMED "PLASMA PUMP ERROR" - DIRECTIONS WERE FOLLOWED FOR TROUBLESHOOTING ALARMS 3 SEPARATE TIMES. ALARMS COULD NOT BE PASSED. TUBING REMOVED NEW TUBING SET RETRIEVED USED AND PRIMED/PROCEDURE DONE WITHOUT INCIDENT OF ALARMS.