inforMED
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

12320

Lot 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.