BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FILTER, INTRAVENOUS,PALL POSIDYNE ELD

    MDR report key: 2192041 · Received July 30, 2011

    Report

    Report Number
    2192041
    Event Type
    Malfunction
    Date Received
    July 30, 2011
    Date of Event
    June 21, 2011
    Report Date
    July 30, 2011
    Manufacturer
    PALL POSIDYNE ELD, INTRAVENOUS FILTER
    Product Code
    FPB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    APPROXIMATELY THIRTY MINUTES INTO THE INFUSION, THE PUMP ALARMED WITH A DOWNSTREAM OCCLUSION. THE PRESSURE INCREASED ON THE PUMP. THE OCCLUSION WAS UNRESOLVED. THERE WAS BLOOD RETURN PRESENT IN THE LINE. THE PHARMACIST WAS NOTIFIED OF THE LINE ISSUE. THE PRACTITIONER WAS UNABLE TO RESOLVE THE "BLOCK" IN THE FILTER. THE PRACTITIONER WAS INSTRUCTED TO PRIME A NEW FILTER WITH DEXTROSE 5% AND WATER AND REPLACE THE FILTER. A NEW FILTER WAS APPLIED AND THE DRUG INFUSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FILTER, INTRAVENOUS,PALL POSIDYNE ELD PALL MEDICAL FPB PALL POSIDYNE ELD, INTRAVENOUS FILTER * 106011

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR