BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA OPTIA EXCHANGE SET

    MDR report key: 2150738 · Received June 29, 2011

    Report

    Report Number
    MW5021218
    Event Type
    Injury
    Date Received
    June 29, 2011
    Date of Event
    June 2, 2011
    Report Date
    June 29, 2011
    Manufacturer
    CARIDIANBC
    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 LOSS. PLASMA EXCHANGE SET PRIMED WITHOUT INCIDENT. PATIENT PROCEDURE STARTED. MULTIPLE CENTRIFUGE PRESSURE ALARMS WITHIN 5 MINUTES. CENTRIFUGE INSPECTED AND IT WAS NOTED THAT THE MULTI-LUMEN TUBING LOCATED BETWEEN THE UPPER AND LOWER COLLAR HOLDERS WAS WEARING THROUGH. RINSEBACK COULD NOT BE PERFORMED. PROCEDURE WAS ABORTED. PATIENT BLOOD LOSS APPROXIMATED AT 185 ML.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Other