MalfunctionGKT
APHERESIS KIT
Received Apr 1, 2021 · Event occurred Mar 26, 2021
Report MW5100510 · MDR key 11607943
Device
Generic name
Separator, Automated, Blood Cell, Diagnostic
Manufacturer
Terumo Bct, Inc.Lot number
2010093130
Product problems
- Device Alarm System
- Complete Blockage
Patient
63 YR
- Insufficient Information
- Insufficient Information
Narrative
Description of Event or Problem
PATIENT UNDERWENT AUTOLOGOUS STEM CELL COLLECTION (B)(6) 2021. AT THE END OF COLLECTION, PRODUCT WAS NOTED TO BE CLOTTED AND UNSUITABLE FOR USE. AS A RESULT, THE PRODUCT WAS DISCARDED. TERUMOBCT WAS NOTIFIED. IT WAS FOUND THE SECOND BAG OF ACD-A HUNG WAS NOT PROPERLY INFUSING INTO THE PRODUCT, THOUGH NO ALARMS WERE PRODUCED TO NOTIFY THE OPERATOR OF THE INTERRUPTED AC FLOW. APHERESIS KIT # 2010093130, EXP 10/1/22; ACD-A, LOT # 20044084, EXP 10/1/22. THE PATIENT HAD TO RETURN A SUBSEQUENT TO RE-COLLECT. FDA SAFETY REPORT ID# (B)(4).