BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OUTLOOK ES

    MDR report key: 3140019 · Received May 29, 2013

    Report

    Report Number
    1641965-2013-00025
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    April 16, 2013
    Report Date
    April 30, 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

    THE REPORTED COMPLAINT WAS NOT CONFIRMED, NOR WAS IT DUPLICATED. BASED ON THE INITIAL REPORT OF OVER INFUSION, THE PUMP OPERATION LOG WAS REVIEWED, AND A VOLUMETRIC ACCURACY TEST WAS COMPLETED, USING THE SETTINGS AS INDICATED BY THE CUSTOMER COMPLAINT AND INDICATED IN THE PUMP OPERATION LOG. THE TEST WAS RUN AS FOLLOWS: FIRST TEST: 40.0 ML OR 101% OF EXPECTED VOLUME. SECOND TEST: 39.9 ML OR 101% OF EXPECTED VOLUME. THIRD TEST: 39.9 ML OR 101% OF EXPECTED VOLUME. THE PUMP PERFORMED WITHIN SPECIFICATION DURING ALL THREE TESTS. BASED ON THE REVIEW OF THE OPERATION LOG, THE UPDATED INFORMATION FORM THE CUSTOMER ON (B)(4) 2013, AND THE RESULTS OF THE VOLUMETRIC TESTING LISTED ABOVE, THE COMPLAINT WAS NOT CONFIRM NOR WAS IT DUPLICATED.

    Description of Event or Problem · 1

    INCIDENT DATE:(B)(6) 2013. REPORT DATE: (B)(4) 2013 THE NURSE STATES, "I HUNG A SECONDARY SET FOR A ANTIBIOTIC FOR 1 HOUR. WHEN I WALKED BACK IN THE ROOM WITHIN 10 MINUTES THE ENTIRE PIGGYBACK MED HAD INFUSED BUT THE PUMP SAID THERE WAS STILL 80 ML TO INFUSE ON THE PUMP. I TOOK THE PUMP OUT OF SERVICE AND NOTIFIED BIOMED." AT THIS TIME NO PATIENT INJURY WAS NOTED. DATE (B)(4) 2013 UPDATE: CUSTOMER STATES THE ISSUE WITH THE PUMP AS, "THE PUMP DID NOT HAVE AN OVERDOSE ISSUE, THE SECONDARY INFUSION WAS RUNNING AT 100 ML/HOUR, THERE WAS PRIMARY ALSO WAS INFUSING, THE PUMP SAID I BELIEVE THERE WAS STILL 40 ML TO INFUSE BUT THE BAG WAS EMPTY".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    233795 OUTLOOK ES INFUSION PUMP FRN B. BRAUN MEDICAL, INC. OUTLOOK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention