BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROFUSE RAPID RATE INFUSER

    MDR report key: 2357791 · Received October 12, 2011

    Report

    Report Number
    3006222357-2011-00003
    Event Type
    Malfunction
    Date Received
    October 12, 2011
    Date of Event
    August 23, 2011
    Report Date
    October 3, 2011
    Manufacturer
    NUMIA MEDICAL TECHNOLOGY, LLC
    Product Code
    FRN
    PMA / PMN Number
    K091386
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    INSPECTION OF INFUSER REVEALED THAT THE GEAR ASSEMBLY THAT LINKS THE MOTOR TO THE SYRINGE RACK TO ALLOW MOVEMENT WAS SLIPPING. COGS ON THE GEAR WERE STRIPPED AND WOULD RUN FINE WHEN NOT UNDER A LOAD. ONCE PRESSURE WAS APPLIED WHEN ATTEMPTING AN INFUSION THE RESISTANCE WOULD CAUSE THE GEAR TO SLIP.

    Description of Event or Problem · 1

    CUSTOMER WAS USING A MICROFUSE RAPID RATE INFUSER TO DELIVER 30CC OF ADENOSINE USING A 60CC SYRINGE. INFUSION SHOULD HAVE COMPLETED IN 4 MINUTES HOWEVER IT TOOK 5 MINUTES. NO ADVERSE EVENTS RESULTED FROM EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICROFUSE RAPID RATE INFUSER SYRINGE INFUSION PUMP FRN NUMIA MEDICAL TECHNOLOGY, LLC 6001 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other