BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELLEX KIT

    MDR report key: 2370577 · Received December 4, 2011

    Report

    Report Number
    2370577
    Event Type
    Malfunction
    Date Received
    December 4, 2011
    Date of Event
    November 17, 2011
    Report Date
    November 30, 2011
    Manufacturer
    THERAKOS
    Product Code
    LNR
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    THE CLINICIAN WAS PRIMING THE CELLEX MACHINE FOR MORNING TREATMENTS. THE MACHINE ALARMED "RETURN PRESSURE TEST FAILURE ALARMS". WE THEN HAD TWO PRIME "130" ALARMS. THE KIT BROKE LOOSE IN THE CENTRIFUGE AND METAL BEARINGS FROM THE DISPOSABLE KIT BROKE LOOSE. BIO MED WAS CONTACTED AND WILL PICK UP KIT. THERAKOS WAS CONTACTED AND WILL SEND TECH TO FIX MACHINE TOMORROW. WE ARE WAITING FOR THE INVESTIGATION TEST RESULTS FROM THERAKOS INC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CELLEX KIT DISPOSABLE PRODUCT (DESCRIBE BELOW) LNR THERAKOS NA Z317

    Patients

    Seq Age Sex Outcome Treatment
    1 *