MalfunctionLKN
SPECTRA IDL SET
Received Sep 29, 2020 · Event occurred Aug 27, 2020
Report MW5096954 · MDR key 10605937
Device
Generic name
Separator, Automated, Blood Cell And Plasma, Therapeutic
Manufacturer
Terumo Bct Inc.Model number
SPECTRA IDL SETCatalog number
12320
Lot number
20044035
Product problems
- Contamination /Decontamination Problem
Patient
79 YR
- Insufficient Information
- Insufficient Information
Narrative
Description of Event or Problem
PLASMA PUMP ALARMED DURING PROCEDURE A CELLULAR THERAPY COLLECTION PROCEDURE. PLASMA PUMP TUBING OVER TORQUED. FLUID NOTED WHEN DEVICE DOOR WAS OPENED. PROCEDURE WAS HALTED UNDER THE GUIDANCE OF THE MD AND JUNO DUE TO POSSIBLE CELLULAR THERAPY PRODUCT (CTP) CONTAMINATION. THE WHOLE BLOOD PROCESSED WAS 2.948 LITERS WITH A COLLECTED CTP VOLUME OF 30 ML. NO RINSEBACK WAS PERFORMED. THE OPTIA SPECTRA KIT LOT # 20044036. DEVICE # 6 (SERIAL#: (B)(4)). FDA SAFETY REPORT ID# (B)(4).