BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA OPTIA EXCHANGE SET

    MDR report key: 2150751 · Received June 29, 2011

    Report

    Report Number
    MW5021219
    Event Type
    Injury
    Date Received
    June 29, 2011
    Date of Event
    June 3, 2011
    Report Date
    June 29, 2011
    Manufacturer
    CARIDIANBCT
    Product Code
    LKN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    CARIDIANBCT SPECTRA OPTIA PLASMA EXCHANGE SET LOT # 05T3105 FAILURE RESULTING IN PATIENT BLOOD SPILL AND LOSS. PLASMA EXCHANGE SET PRIME WITHOUT INCIDENT. PATIENT PROCEDURE STARTED. AT 3 MINUTES RUN TIME, THE OPERATOR NOTED BLOOD LEAKING FROM THE CENTRIFUGE. THE PROCEDURE WAS IMMEDIATELY STOPPED. INSPECTION OF THE CENTRIFUGE COMPARTMENT REVEALED THAT THE MULTI-LUMEN TUBING LOCATED NEAR THE LOWER COLLAR HOLDER HAD COMPLETELY BROKEN APART FROM THE SET AND HAD PULLED OUT FROM THE PROTECTIVE SLEEVE. NO WARNING ALARMS HAD OCCURRED PRIOR TO THE BREAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPECTRA OPTIA EXCHANGE SET OPTIAL TPE SET LKN CARIDIANBCT OPTIA 05T3105

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other