BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPECTRA OPTIA APHERESIS

    MDR report key: 17267638 · Received July 5, 2023

    Report

    Report Number
    MW5119116
    Event Type
    Death
    Date Received
    July 5, 2023
    Date of Event
    April 24, 2023
    Report Date
    June 30, 2023
    Manufacturer
    TERUMO BCT, INC.
    Product Code
    LKN
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    501
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    A PATIENT WITH CRITICAL MEDICAL CONDITIONS REQUIRED A THERAPEUTIC PLASMA EXCHANGE FOR PULMONARY HEMORRHAGE. AFTER THE THIRD UNIT OF THAWED PLASMA WAS EXCHANGED, USING THE TERUMO OPTIA INSTRUMENT, THE PATIENT EXPIRED. THE BLOOD BANK MEDICAL DIRECTOR DOES NOT SUSPECT THE BLOOD PRODUCT, NOR THE INSTRUMENT CONTRIBUTED TO THE DEATH; HOWEVER, A THOROUGH INVESTIGATION IS CURRENTLY IN PROGRESS. WE WILL SUBMIT A FORMAL COMPLETE REPORT BASED ON THE ROOT CAUSE ANALYSIS ONCE IT IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2040436 SPECTRA OPTIA APHERESIS SEPARATOR, AUTOMATED, BLOOD CELL AND PLASMA, THERAPEUTIC LKN TERUMO BCT, INC. 610000

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Male Death THAWED PLASMA