BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TERUMO SPECTRA OPTIA APHERESIS SYSTEM TUBING

    MDR report key: 13966607 · Received March 30, 2022

    Report

    Report Number
    MW5108655
    Event Type
    Injury
    Date Received
    March 30, 2022
    Date of Event
    March 24, 2022
    Report Date
    March 28, 2022
    Manufacturer
    TERUMO BCT, INC.
    Product Code
    LKN
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    BLOOD LEAK IN PLASMAPHERESIS TUBING DURING PROCEDURE. THIS IS THE 3RD TIME THIS RECENTLY HAPPENED USING THIS TYPE OF TUBING DURING THIS PROCEDURE. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    872861 TERUMO SPECTRA OPTIA APHERESIS SYSTEM TUBING SEPARATOR, AUTOMATED, BLOOD CELL AND PLASMA, THERAPEUTIC LKN TERUMO BCT, INC. 2203033130
    872862 TERUMO SPECTRA OPTIA APHERESIS SYSTEM TUBING SEPARATOR, AUTOMATED, BLOOD CELL AND PLASMA, THERAPEUTIC LKN TERUMO BCT, INC. 2203033130
    872863 TERUMO SPECTRA OPTIA APHERESIS SYSTEM TUBING SEPARATOR, AUTOMATED, BLOOD CELL AND PLASMA, THERAPEUTIC LKN TERUMO BCT, INC. 2203033130

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Female