InjuryGKT
COBE SPECTRA WHITE BLOOD CELL SET-FUNCTIONALLY CLOSED
Received Dec 19, 2012 · Event occurred Nov 13, 2012
Report MW5028328 · MDR key 2887641
Device
Product problems
- Fluid/Blood Leak
- Connection Problem
Patient
50 YR
- No Information
Narrative
Description of Event or Problem
THE DEVICE WAS SET-UP FOR A STEM CELL COLLECTION AND ONCE THE PROCEDURE STARTED A SMALL AMOUNT OF FLUID WAS NOTED TO BE LEAKING FROM THE COLLECTION BAG TUBING. UPON ASSESSMENT IT WAS NOTED THAT THE LEAKING WAS COMING FROM THE CONNECTION BELOW THE ACDA FILTER. THE CONNECTION WAS LOOSE AND NOT PROPERLY SEALED. (B)(6).