BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KIT, PHOTOPHERESIS PROCEDURAL

    MDR report key: 2117348 · Received May 30, 2011

    Report

    Report Number
    2117348
    Event Type
    Malfunction
    Date Received
    May 30, 2011
    Date of Event
    April 14, 2011
    Report Date
    May 29, 2011
    Manufacturer
    THERAKOS CELLEX
    Product Code
    LNR
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING THE DRAWING PHASE OF TREATMENT (PHOTOPHERESIS PROCEDER), THERE WERE AIR BUBBLES NOTED THAT WERE SEEPING INTO THE FILTER AT THE T CONNECTOR WHERE THE SALINE JOINS THE RETURN LINE. THE FILTER TOO BECAME FILLED WITH AIR. THE AIR DECTECTED ALARMS WERE RAISED AND THE TREATMENT ABORTED. THERE WAS A MANUAL RETURN OF BLOOD INFUSED INTO THE PT WITHOUT INCIDENT. A NEW CELLEX KIT WITH A DIFFERENT CELLEX MACHINE WAS REPRIMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KIT, PHOTOPHERESIS PROCEDURAL PHOTOPHERESIS PROCEDURAL KIT LNR THERAKOS CELLEX * Y307/158

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR