BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OUTLOOK

    MDR report key: 3123926 · Received May 15, 2013

    Report

    Report Number
    1641965-2013-00024
    Event Type
    Malfunction
    Date Received
    May 15, 2013
    Date of Event
    April 16, 2013
    Manufacturer
    B. BRAUN MEDICAL, INC.
    Product Code
    FRN
    PMA / PMN Number
    K011975
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION RESULTS: THE OPERATION LOG WAS THOROUGHLY REVIEWED, FOCUSED WITHIN THE TIME FRAME OF THE REPORTED EVENT. NO INFUSION ISSUES WERE NOTED. ADDITIONALLY, IN AN ATTEMPT TO DUPLICATE THE REPORTED ISSUE, THE PUMP WAS SET UP FOR VOLUMETRIC TESTING WITH SETTINGS TAKEN FROM THE OPERATION LOG FOR THE TIME FRAME OF THE REPORTED EVENT, AS FOLLOWS: 3X VOLUMETRICS OF 100ML/HR AND 32.8ML (PIGGYBACK): 1ST TEST - 32.7ML OR 99% OF EXPECTED VOLUME; 2ND TEST - 32.9ML OR 101% OF EXPECTED VOLUME; 3RD TEST: 33.0ML OR 101% OF EXPECTED VOLUME. ALL TESTS PASSED AND THE PUMP PERFORMED WITHIN SPEC.

    Description of Event or Problem · 1

    CUSTOMER STATES THAT A LEVAQUIN 100ML BAG WAS SET UP TO BE INFUSED AS PIGGYBACK, SECONDARY INFUSION. CUSTOMER DID NOT KNOW THE RATE OF THE INFUSION FOR EITHER THE PRIMARY OR THE SECONDARY. THE LEVAQUIN INFUSED IN 10 MINUTES PER THE NURSE COMING TO CHECK ON THE PT. THE PT'S ARM WAS RED AT THE IV SITE, BUT NO TREATMENT WAS GIVEN. INCIDENT DATE: (B)(6) 2013. NO TUBING AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    215142 OUTLOOK INFUSION PUMP FRN B. BRAUN MEDICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention