MalfunctionGKT
SPECTRA OPTIA
Received Sep 13, 2021 · Event occurred Jul 30, 2021
Report 12459370 · MDR key 12459370
Device
Generic name
Separator, Automated, Blood Cell, Diagnostic
Manufacturer
Terumo Bct, Inc.Model number
12220Catalog number
12220
Lot number
2105273230
Product problems
- Incomplete or Inadequate Priming
Patient
Not reported
- Insufficient Information
- Insufficient Information
Narrative
Description of Event or Problem
TUBING MALFUNCTIONED DURING PRIMING AND SET-UP UNABLE TO BE FINISHED. WE SUSPECT THE ISSUE IS WITH THE FILTER ASSOCIATED WITH THE ANTICOAGULANT LINE. THIS OCCURRED ON TWO DIFFERENT SETS WITH DIFFERENT LOT NUMBERS.