BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OUTLOOK ES

    MDR report key: 3231828 · Received July 15, 2013

    Report

    Report Number
    1641965-2013-00041
    Event Type
    Malfunction
    Date Received
    July 15, 2013
    Date of Event
    June 22, 2013
    Report Date
    June 25, 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
    IA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    AFTER THE ANALYSIS OF THE PUMP THE REPORTED COMPLAINT OF BATTERY EXPLOSION WAS NOT CONFIRMED; HOWEVER, THE OVERHEATING OF THE PUMP WAS DUPLICATED AND CONFIRMED. THE PUMP WAS OVERCHARGING CAUSING THE MAIN BATTERY TO OVERHEAT. THE BATTERY WAS CONTINUING TO CHARGE AT THE INITIAL CHARGE LEVEL OF 15 VOLTS INSTEAD OF REVERTING TO THE 14 VOLT MAINTENANCE CHARGE. BATTERIES WERE CHARGED FOR A DURATION OF 8 HOURS EACH THAT RESULTED IN THE OVERCHARGING OF THE BATTERY WHICH CAUSED THE OVERHEATING. THE PUMP WAS RAN AT 600 ML/HR FOR 2 HOURS DURING THE OVERCHARGING/OVERHEATING OF THE PUMP WITH NO VOLUMETRIC ERRORS OR ALARMS DISPLAYED. THE ROOT CAUSE WAS DETERMINED TO BE THE CHARGING IC, PART NUMBER (B)(4), ON THE MAIN BOARD OF THE UNIT. THE MAIN BOARD, (B)(4), AND MAIN BATTERY, (B)(4), WERE REPLACED TO CORRECT THE ISSUE. PREVENTATIVE MAINTENANCE WAS ALSO PERFORMED. THE SERVICE REPORTS ON THIS PUMP WAS PULLED DURING THE INVESTIGATION. THE PUMP HAD BEEN SENT IN FOR SERVICE ON 3 DIFFERENT OCCASIONS FOR LOSS OF THE DRUG LIBRARY. ON THE LAST DATE OF SERVICE, THE PUMPS MAIN BOARD AND COSMETIC BEZEL WAS REPLACED IN WHICH RESOLVED THE DRUG LIBRARY ISSUE.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THEY HAVE SENT THIS PARTICULAR PUMP IN ON NUMEROUS OCCASIONS FOR NOT UPLOADING CONFIGURATIONS. UPON THE RETURN OF THE PUMP THE CUSTOMER WAS PERFORMING PREVENTATIVE MAINTENANCE AND RUNNING MANY TESTS. AFTER RUNNING THE TESTS, THEY BEGAN VOLUMETRIC TESTING AND THEN THE PUMP BEGAN SOUNDING MANY ALARMS. SHORTLY THEREAFTER, THE PUMP BEGAN SMOKING AND WAS HOT TO THE TOUCH. THEY UNPLUGGED THE PUMP AND CHECKED THE BATTERY. THE BATTERY WAS REPLACED AND WAS DATED 2012. A FEW DAYS LATER THEY PLUGGED THE PUMP BACK IN AND ALLOWED IT TO RUN. A FEW HOURS LATER, THEY CHECKED THE PUMP AND IT AGAIN WAS SMOKING. THERE WERE NO INJURIES FROM THE EVENT AND NO PT INVOLVEMENT AS EVERYTHING TOOK PLACE IN THE BIOMED LAB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    327777 OUTLOOK ES INFUSION PUMP FRN B. BRAUN MEDICAL, INC. 621-400ES

    Patients

    Seq Age Sex Outcome Treatment
    1 Other