MalfunctionGKT
PHERESIS KIT
Received Apr 10, 2019 · Event occurred Jan 21, 2019
Report 8499972 · MDR key 8499972
Device
Generic name
Separator, Automated, Blood Cell, Diagnostic
Manufacturer
Terumo Bct, Inc.Model number
1810043130Product problems
- Fluid/Blood Leak
- Tear, Rip or Hole in Device Packaging
Patient
21900 DA
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
PHERESIS MACHINE DETECTED A FLUID LEAK. PROCEDURE STOPPED AND TUBING BELT IN CENTRIFUGE CHANNEL HAD A TEAR IN IT AND BLOOD LEAKED OUT. UNABLE TO RINSEBACK. PHERESIS PROCEDURE WAS ABORTED AND REMAINDER OF PROCEDURE RUN TIME WAS FINISHED ON PHERESIS MACHINE #1.