BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROFUSE DUAL RATE INFUSER

    MDR report key: 2348920 · Received September 14, 2011

    Report

    Report Number
    3006222357-2011-00002
    Event Type
    Malfunction
    Date Received
    September 14, 2011
    Date of Event
    August 16, 2011
    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 Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON OPENING THE PUMP, IT WAS DISCOVERED THAT THE CABLE WHICH CONNECTS THE OPTOSWITCH AND THE MAIN PC BOARD HAD BROKEN LEAD PINS ON THE OPTOSWITCH SIDE. IN THE PAST, WE HAVE HAD INSTANCES WHERE THE CONNECTION HAD WORKED LOOSE BUT NOT WITH BROKEN PINS. UNABLE TO DETERMINE DEFINITE CAUSE OF THE PINS BREAKING. WILL MONITOR TO SEE IF WE HAVE ANY REPEAT INSTANCES OF THIS PROBLEM AND HOPEFULLY THAT WILL HELP US DETERMINE A CAUSE. THE INFUSER WAS REPAIRED AND RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    DEVICE RAN CONSTANTLY FOR APPROXIMATELY 4 SECONDS AND THEN ALARMED AND STOPPED. FAILED DURING PREPARATION FOR INFUSION, NO ADVERSE EFFECT ON PATIENT. BY DESIGN THE INFUSER RECOGNIZED INSTANCES WHEN THE MOTOR OPERATION DOES NOT CONFORM TO THE EXPECTED INFUSION PROFILE AND WILL ALERT THE USER WITH AN ALARM AND STOP THE INFUSION. THE DEVICE RESPONDED TO THE PROBLEM AS IT SHOULD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICROFUSE DUAL RATE INFUSER SYRINGE INFUSION PUMP FRN NUMIA MEDICAL TECHNOLOGY, LLC 6003 NA

    Patients

    Seq Age Sex Outcome Treatment
    1