MalfunctionGKT
SPECTRA OPTIA
Received Sep 23, 2022 · Event occurred Sep 13, 2022
Report 15470203 · MDR key 15470203
Device
Generic name
Separator, Automated, Blood Cell, Diagnostic
Manufacturer
Terumo Bct, Inc.Model number
2204223230Product problems
- Crack
Patient
27375 DA · Female
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
INJECTOR PORT HAD A SMALL CRACK IN IT THAT WAS DISCOVERED WHEN TRYING TO INJECT ACDA INTO PRODUCT BAG. COLLECTION BAG WAS THEN CONSIDERED CONTAMINATED. PROCEDURE WAS STOPPED AND A NEW KIT INSTALLED.