BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECP

    MDR report key: 2068469 · Received April 7, 2011

    Report

    Report Number
    2068469
    Event Type
    Malfunction
    Date Received
    April 7, 2011
    Date of Event
    March 16, 2011
    Report Date
    April 5, 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

    DURING THE EXTRACORPOREAL PHOTOPHORESIS TREATMENT (ECP), THERE WERE MULTIPLE BLOOD PUMP ALARMS. THE PRACTITIONER WAS UNABLE TO RESOLVE THEM PER THE INSTRUMENT ADJUSTMENTS AS INDICATED. ADDITIONAL MULTIPLE SYSTEM PRESSURE ALARMS OCCURRED. THERE WAS NO EVIDENCE OF CLOTS, AIR BUBBLES OR KINKED TUBING. THE PRACTITIONER WAS UNABLE TO RESOLVE THEM. THERAKOS WAS NOTIFIED AND THE TREATMENT ENDED WITH ALL BLOOD PRODUCTS BEING RETURNED TO THE PT AND THERE WAS NO BLOOD LOSS. THE OUTCOME WAS AN INCOMPLETE TREATMENT WITH NO WHITE BLOOD CELLS (WBCS) COLLECTED OR TREATED. THE VITAL SIGNS WERE STABLE AND THE PT ASYMPTOMATIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECP ECP LNR THERAKOS ECP Y305

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR