BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA OPTIA

    MDR report key: 20610376 · Received November 4, 2024

    Report

    Report Number
    MW5162142
    Event Type
    Injury
    Date Received
    November 4, 2024
    Date of Event
    September 27, 2024
    Report Date
    October 30, 2024
    Manufacturer
    TERUMO BCT, INC.
    Product Code
    LKN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TN, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT ADMITTED TO CARDIAC CARE UNIT FOR HELLP SYNDROME. PLAN FOR THERAPEUTIC PLASMA EXCHANGE X5 TREATMENTS OVER 7 DAYS. WHEN LOADING PLASMAPHERESIS MACHINE FOR FIRST TREATMENT, THERE WAS A MALFUNCTION OF A SENSOR AND THE TUBING WOULD NOT LOAD. NOTIFIED MANAGER AND MD ON CALL OF ISSUE. BIOMED AND OPTIA REP HELPED WITH TROUBLESHOOTING, BUT MACHINE CONTINUED TO MALFUNCTION. URGENT TRANSFER ORDERS WERE PLACED FOR APHERESIS TREATMENT. PATIENT TREATED WITH 1000MG SOLUMEDROL AND 2 L FRESH FROZEN PLASMA PRIOR TO TRANSFER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1460692 SPECTRA OPTIA SEPARATOR, AUTOMATED, BLOOD CELL AND PLASMA, THERAPEUTIC LKN TERUMO BCT, INC. 61000

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Female Required Intervention