MalfunctionGKT

SPECTRA OPTIA

Received May 12, 2023 · Event occurred Apr 19, 2023

Report 16918443 · MDR key 16918443

Device

Generic name

Separator, Automated, Blood Cell, Diagnostic

Manufacturer

Terumo Bct, Inc.

Lot number

2302133141

Product problems

Device Alarm System
Output Problem

Patient

24820 DA · Unknown

Insufficient Information
Insufficient Information

Narrative

Description of Event or Problem

PROCEDURE TREATMENT FOR THERAPEUTIC PLASMA EXCHANGE ON THE OPTIA MACHINE WITH A TERUMO BCT KIT. MULTIPLE ALARMS NOTED DURING PROCEDURE AND TERUMO BCT NOTIFIED. UNABLE TO CLEAR ALARMS AND NOT ABLE TO RINSE BACK. TREATMENT STOPPED AND RESTARTED WITH NEW KIT ON DIFFERENT MACHINE. MANUFACTURER RESPONSE FOR TERUMO BCT, (BRAND NOT PROVIDED) (PER SITE REPORTER) THE MANUFACTURER EXCHANGED THE DEVICE.