SPECTRA OPTIA APHERESIS SYSTEM
Received Sep 6, 2019 · Event occurred Jul 5, 2019
Report 8968891 · MDR key 8968891
Device
Generic name
Separator, Automated, Blood Cell, Diagnostic
Manufacturer
Terumo Bct, Inc.Catalog number
10220
Lot number
1904233130
Product problems
- Leak/Splash
Patient
26645 DA
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
APPROX. 2 MIN. INTO RINSEBACK OF THERAPEUTIC PLASMA EXCHANGE, NURSE NOTED THERE WAS LEAKAGE UNDER THE KIT'S CASSETTE NEAR WHERE THE RETURN TUBING EXITS OUT OF THE KIT'S CASSETTE. NURSE IMMEDIATELY CLAMPED THE RETURN LINE, THE DRAW LINE WAS ALREADY CLAMPED, STOPPED THE RINSEBACK, AND DISCONNECTED THE PATIENT FROM THE MACHINE. THE PHERESIS CATHETER WAS SOON REMOVED BY DOCTOR. TERUMO WAS CALLED AND WILL SEND SERVICE REP. TO CHECK THE MACHINE. THE KITS WITH THE SAME LOT NUMBER WERE SEQUESTERED AND THE AFFECTED KIT WAS PLACED IN A BIOHAZARD BAG AND WAS MAILED TO THE COMPANY.