InjuryGKT
SEPARATOR, AUTOMATED, BLOOD CELL, DIAGNOSTIC
Received Jan 29, 2021 · Event occurred Dec 15, 2020
Report MW5099119 · MDR key 11261212
Device
Generic name
Separator, Automated, Blood Cell, Diagnostic
Manufacturer
Terumo Bct Inc.Model number
90819Catalog number
90819
Lot number
09D15004
Product problems
- Disconnection
- Loose or Intermittent Connection
Patient
Not reported
- Insufficient Information
- Insufficient Information
Narrative
Description of Event or Problem
UPON DEBULKING A MARROW ON THE COBE CELL WASHER, A LINE BECAME LOOSE AND DISCONNECTED FROM THE COBE BAG. WE OPENED UP ANOTHER BAG OF THE SAME LOT AND TRIED TO RE-CREATE THE EVENT, BUT COULDN'T GET THE LINE TO LOOSEN OR PULL AWAY FROM THE BAG. WE THINK IT WAS A FAULTY BAG INITIALLY. FDA SAFETY REPORT ID # (B)(4).