BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CELLEX PHOTOPHERESIS (ECP) PROCEDURE KIT

    MDR report key: 5892919 · Received August 17, 2016

    Report

    Report Number
    MW5064206
    Event Type
    Injury
    Date Received
    August 17, 2016
    Date of Event
    July 18, 2016
    Report Date
    August 17, 2016
    Manufacturer
    THERAKOS
    Product Code
    LNR
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    AFTER FOURTEEN (14) MINUTES INTO AN CELLEX EXTRACORPOREAL PHOTOPHERESIS PROCEDURE (ECP), THE CENTRIFUGE BOWL SHATTERED AND 209 ML OF PT BLOOD WAS LOSS. NO ALARMS OCCURRED DURING PRIMING. THE PROCEDURE WAS ABORTED AND THE ATTENDING PHYSICIAN WAS NOTIFIED. POST EVENT COMPLETE BLOOD COUNT SAMPLE WAS DRAWN. THE PT WAS ALSO TO PERFORM ANOTHER PROCEDURE USING A DIFFERENT CELLEX MACHINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    533874 CELLEX PHOTOPHERESIS (ECP) PROCEDURE KIT ECP CENTRIFUGE LNR THERAKOS E326

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR