BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROFUSE EXTENDED RATE INFUSER

    MDR report key: 2348953 · Received September 14, 2011

    Report

    Report Number
    3006222357-2011-00001
    Event Type
    Malfunction
    Date Received
    September 14, 2011
    Date of Event
    October 26, 2010
    Report Date
    September 8, 2011
    Manufacturer
    NUMIA MEDICAL TECHNOLOGY, LLC
    Product Code
    FRN
    PMA / PMN Number
    K091386
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON OPENING THE PUMP, IT WAS DISCOVERED THAT CORROSION HAD FORMED ON THE CONNECTORS FOR BOTH THE PC BOARD AND OPTOSWITCH BOARD IN THE DEVICE AND WAS DISRUPTING OPERATION. THE CORROSION WAS CLEANED OFF THE CONNECTORS AND THEN RECONNECTED. ONCE REASSEMBLED, THE INFUSER WAS RETESTED AND PASSED ALL TESTS AND NO LONGER EXHIBITED THE REPORTED MALFUNCTION. IT APPEARS THAT SOME LIQUID WAS SPILLED ON THE DEVICE AND HAD LEAKED THROUGH TO THE INTERNAL COMPONENTS WHICH CAUSED THE CORROSION.

    Description of Event or Problem · 1

    THIS MDR IS BEING FILED RETROSPECTIVELY. AFTER A REVIEW OF ALL COMPLAINT INFORMATION, THIS INCIDENT WAS DEEMED REPORTABLE. DEVICE INFUSED VERY FAST WHEN TURNED ON AND THEN ALARMED AND STOPPED. THIS HAPPENED WHILE A PATIENT WAS BEING INFUSED, BUT THERE WERE NO ADVERSE EFFECTS. INFUSION WAS HALTED AS SOON AS THE FASTER THAN NORMAL RATE WAS NOTICED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICROFUSE EXTENDED RATE INFUSER SYRINGE INFUSION PUMP FRN NUMIA MEDICAL TECHNOLOGY, LLC 6004 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other