BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CELLEX

    MDR report key: 4174234 · Received October 8, 2014

    Report

    Report Number
    MW5038572
    Event Type
    Injury
    Date Received
    October 8, 2014
    Date of Event
    September 22, 2014
    Report Date
    October 8, 2014
    Manufacturer
    THERAKOS INC
    Product Code
    LNR
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THIS EVENT OCCURRED DURING A PHOTOPHERESIS PROCEDURE. AFTER PROCESSING 1545 ML OF THE PATIENT'S WHOLE BLOOD AND JUST BEFORE COLLECTING THE BUFFY COAT, A LOUD NOISE COMING FROM THE CENTRIFUGE COMPARTMENT WAS HEARD. BLOOD LEAK ALARM SOUNDED. IMMEDIATELY THE PATIENT'S ACCESS AND RETURN LINES WERE CLAMPED. UPON VISUAL INSPECTION OF THE CENTRIFUGE CHAMBER, IT WAS NOTED THE DRIVE TUBE INSIDE THE CENTRIFUGE BROKE CAUSING A LARGE BLOOD LEAK IN THE CENTRIFUGE COMPARTMENT. THE MD WAS NOTIFIED AND THE PROCEDURE WAS ABORTED. THE BLOOD LOSS WAS APPROXIMATELY 140 ML. THE PATIENT'S VITAL SIGNS WERE STABLE AND THE PATIENT WAS DISCHARGED HOME ASYMPTOMATIC. THE DEFECTIVE KIT WAS SAVE AND SENT TO THE MANUFACTURER FOR INVESTIGATION. REPORT PENDING. DEVICE REMOVED FROM SERVICE AND SINCE THE EVENT OCCURRED THE MACHINE HAS BEEN SERVICED AND DEEMED READY FOR USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    632775 CELLEX CELLEX PHOTOPHERESIS KIT LNR THERAKOS INC CELLEX C334

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention SERIAL # (B)(4)| THERAKOS CELLEX PHOTOPHERESIS SYSTEM,