inforMED
MalfunctionGKT

SPECTRA OPTIA®

Received Jul 8, 2024 · Event occurred Mar 12, 2024

Report 19688862 · MDR key 19688862

Device

Generic name

Separator, Automated, Blood Cell, Diagnostic

Manufacturer

Terumo Bct, Inc.

Model number

12220

Catalog number

12220

Lot number

2308213241

Patient

2 MO · Male

  • No Clinical Signs, Symptoms or Conditions
  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

DURING A ROUTINE PLASMA EXCHANGE THE CONNECTION (LUER TYPE) BETWEEN THE APHERESIS SET AND THE WARMER TUBING SET VIBRATED LOOSE ALLOWING < 100 ML OF BLOOD LOSS. DURING SETUP THIS OPERATOR ENSURED THE CONNECTION WAS VERY TIGHT (AS THIS INCIDENT HAS HAPPENED BEFORE) AND WHEN LEAK WAS DISCOVERED IT WAS FOUND TO BE "FINGER TIGHT." THERE WAS NO COMPLETE SEPARATION OF THE LINES, BUT ENOUGH THAT BLOOD WAS ALLOWED TO LEAK OUT VIA THE THREADED CONNECTION. THE CONNECTION WAS RE-TIGHTENED AND MONITORED THE REMAINDER OF THE PROCEDURE. PATIENT WAS STABLE THROUGHOUT, NO CHANGES IN HGB/HCT NOTED.