MalfunctionGKT
SPECTRA OPTIA IDL SET
Received Aug 13, 2024 · Event occurred Feb 21, 2024
Report 19972023 · MDR key 19972023
Device
Generic name
Separator, Automated, Blood Cell, Diagnostic
Manufacturer
Terumo Bct, Inc.Model number
12320Lot number
2306166141
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
ATTEMPTED 2 TIMES TO PRIME TUBING FOR PROCEDURE WITH THE SAME ALARM SOUNDING DURING THE PRIMING PROCESS ("RETURN LINE AIR DETECTOR FAILED FLUID CHECK"). WE CHANGED APHERESIS MACHINES AND AGAIN GOT THE SAME ALARM SOUNDING. SO FAILURE WITH 3 SEPARATE TUBINGS, ALL OF THE SAME LOT NUMBER. SUCCESSFUL WITH PRIMING THE MACHINE WITH THE 4TH TUBING USING A DIFFERENT LOT NUMBER. CONTACTED TERUMOBCT ABOUT PROBLEM AND THE REP STATED THEY HAVE SEEN AN INCREASE IN THIS ALARM. NO HARM TO PATIENT.