BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROFUSE

    MDR report key: 2709462 · Received August 7, 2012

    Report

    Report Number
    3006222357-2012-00001
    Event Type
    Malfunction
    Date Received
    August 7, 2012
    Date of Event
    July 25, 2012
    Report Date
    August 7, 2012
    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 RECEIPT, WE SUBJECTED THE INFUSER TO PERFORMANCE TEST PER OUR FINAL TESTING PROCEDURE. THE PUMP PERFORMED WITHIN SPECIFICATION. REQUESTED OUR LAB TECHNICIANS RUN A FLOW PROFILE ON THE INFUSER AND IT ACCURATELY DELIVERED A 30 CC SYRINGE IN 6.01 MINS, THE SPECIFICATION STATES THAT IT SHOULD TAKE (B)(4). WE WERE UNABLE TO GET THE DEVICE TO EXHIBIT ANY EVIDENCE OF INFUSING TOO FAST.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THEIR MICROFUSE RAPID RATE INFUSER WAS INFUSING TOO FAST. THERE WAS NO PT INVOLVED AND NO OPERATOR INJURY INVOLVED. INFUSER WAS RETURNED TO MFR FOR ROOT-CAUSE INVESTIGATION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1