BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LMA TELEFLEX PNC PUMP

    MDR report key: 3830012 · Received May 19, 2014

    Report

    Report Number
    MW5036204
    Event Type
    Malfunction
    Date Received
    May 19, 2014
    Date of Event
    May 12, 2014
    Report Date
    May 16, 2014
    Manufacturer
    LMA
    Product Code
    MEB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    LMA TELEFLEX PUMP WAS CONNECTED TO THE PERIPHERAL NERVE CATHETER ON THE DAY OF SURGERY AND TURNED ON. TWENTY-FOUR HOURS LATER IT WAS NOTED THAT THE BALLOON IN THE DEVICE WAS NOT SMALLER. THE TUBING CLAMPS WERE OPEN, THE RATE WAS SET AT 8ML/HR AS ORDERED, AND THE NERVE CATHETER WAS PATENT. WHEN DISCONNECTED FROM THE PATIENT FLOW WAS NOTED FROM THE DEVICE. A NEW PUMP WAS STARTED AND THIS ONE WORKED PROPERLY. THE PATIENT DID NOT RECEIVE APPROXIMATELY 24 HOURS OF PAIN MEDICATION FROM THE PUMP. DATES OF USE: (B)(6) 2014. DIAGNOSIS OR REASON FOR USE: POST OPERATIVE PAIN CONTROL AFTER ORTHOPEDIC SURGERY. EVENT ABATED AFTER USE: YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    295674 LMA TELEFLEX PNC PUMP TELEFLEX PUMP MEB LMA A130311 PSCFB000US-1

    Patients

    Seq Age Sex Outcome Treatment
    1