MalfunctionLKN
SPECTRA OPTIA
Received Oct 13, 2021 · Event occurred Oct 6, 2021
Report 12623106 · MDR key 12623106
Device
Generic name
Separator, Automated, Blood Cell And Plasma, Therapeutic
Manufacturer
Terumo Bct, Inc.Model number
10220Catalog number
10220
Lot number
20108113130 AND 2109013230
Product problems
- Defective Device
Patient
Not reported
- Insufficient Information
- Insufficient Information
Narrative
Description of Event or Problem
DURING THE SET-UP, THE ANTI-COAGULATION WAS NOT DETECTED IN THE TUBING AND WOULD NOT PASS SET-UP. THE SYSTEM WAS PULLED, AND A NEW SYSTEM USED SUCCESSFULLY. AS SUCH, THE PRODUCT DID NOT REACH THE PATIENT. THIS IS A REPEAT ISSUE, AND WE HAVE TWO SET-UPS WITH THIS REPORT.