BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRA IDL SET

    MDR report key: 10605937 · Received September 29, 2020

    Report

    Report Number
    MW5096954
    Event Type
    Malfunction
    Date Received
    September 29, 2020
    Date of Event
    August 27, 2020
    Report Date
    September 25, 2020
    Manufacturer
    TERUMO BCT INC.
    Product Code
    LKN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    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).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1065750 SPECTRA IDL SET SEPARATOR, AUTOMATED, BLOOD CELL AND PLASMA, THERAPEUTIC LKN TERUMO BCT INC. SPECTRA IDL SET 20044035

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Other