APHERESIS KIT
Received Apr 16, 2021 · Event occurred Apr 14, 2021
Report MW5100829 · MDR key 11684932
Device
Generic name
Separator, Automated, Blood Cell, Diagnostic
Manufacturer
Terumo Bct, Inc.Lot number
4359801
Product problems
- Coagulation in Device or Device Ingredient
- No Flow
Patient
51 YR
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
PATIENT FOR SECOND DAY OF AUTOLOGOUS STEM CELL COLLECTION (B)(6) 2021. DURING PROCEDURE, CLOT NOTED IN COLLECTION BAG. UPON OBSERVATION, NO ACD-A WAS DRAINING FROM THE BAG. MD INFORMED AND ORDERED ADDITIONAL ACD-A TO BE ADDED TO THE PRODUCT. STEM CELL PROCESSING FACILITY NOTIFIED OF CLOTTING ISSUE PRIOR TO SENDING PRODUCT TO THE LAB. OF NOTE, THE RN VISUALIZED THE ACD-A WAS DRIPPING WHEN IT WAS HUNG, AND NO ALARMS WERE MADE BY THE MACHINE. KIT LOT # 2102113130, EXP 2/1/2023; ACD-A LOT # 4359801, EXP 8/22/2021. FDA SAFETY REPORT ID# (B)(4).