BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHOTOPHERESIS PROCEDURAL KIT; CELLEX KIT

    MDR report key: 2117307 · Received May 30, 2011

    Report

    Report Number
    2117307
    Event Type
    Malfunction
    Date Received
    May 30, 2011
    Date of Event
    April 14, 2011
    Report Date
    May 30, 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, AIR WAS DETECTED AT THE START OF PURGING DUE TO AN INITIAL START OF THE MACHINE. AT 450ML MARK OF BLOOD THAT WAS PROCESSED, WE HAD A SYSTEM PRESSURE ALARM. ALL CONNECTIONS WERE TIGHT AND SECURE. THERE WERE FINE TINY AIR BUBBLES AT THE COLLECT PRESSURE DOME AND ALL THE WAY INTO THE BOWL. THE MACHINE WAS RESET AND AFTER THE MACHINE REPURGED ITSELF, THERE WAS ANOTHER SYSTEM PRESSURE ALARM. THE TREATMENT WAS ENDED DUE TO AIR IN MACHINE AND MULTIPLE ALARMS. THE TREATMENT WAS STOPPED AND A MANUAL RETURN OF ALL BLOOD PRODUCTS WAS GIVEN. THE PT TOLERATED IT WELL WITHOUT INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PHOTOPHERESIS PROCEDURAL KIT; CELLEX KIT PHOTOPHERESIS PROCEDURAL KIT; CELLEX KIT LNR THERAKOS CELLEX NA Y307/159

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR