BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OUTLOOK ES

    MDR report key: 2153145 · Received June 17, 2011

    Report

    Report Number
    1641965-2011-00037
    Event Type
    Malfunction
    Date Received
    June 17, 2011
    Date of Event
    May 5, 2011
    Report Date
    May 20, 2011
    Manufacturer
    B. BRAUN MEDICAL, INC.
    Product Code
    FRN
    PMA / PMN Number
    K011975
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVALUATION IS CURRENTLY UNDERWAY. A FOLLOW-UP REPORT WILL BE INITIATED WHEN THE EVALUATION IS COMPLETE.

    Description of Event or Problem · 1

    PIR OVERINFUSION. INCIDENT OCCURRED ON (B)(6), 2011 AT 2:04 PM. BIOMED STATES THAT PATIENT IS "JUST FINE" FROM INCIDENT AND FROM HEART SURGERY. THE PUMP WAS USED IN OR ON A PATIENT DURING HEART SURGERY. NEEDED FOR INSULIN INFUSION FOR A DIABETIC CONDITION. BIOMED ORIGINALLY STATED THE PUMP WAS INFUSING 200 ML, BUT BY THE END OF THE CONVERSATION WITH THE B. BRAUN REPRESENTATIVE, HE HAD CHECKED THE OPERATION LOG AND IT WAS 100 ML AT 0.1 UNITS/HR. THE CLINICIAN CLAIMED THE BAG WAS EMPTY AND THAT THE PUMP NEVER STARTED TO INFUSE. BIOMED COULD NOT FIND ON THE LOG ANY WHERE IT STATED THAT THE PUMP HAD BEEN PROGRAMMED TO START INFUSING. THERE WERE NO FLUIDS ON THE FLOOR. A SAFETY REPORT WAS DONE AND BLOOD TESTS ON THE PATIENT, WHICH WERE FINE. BIOMED RAN 24 HOUR TEST AND THERE WAS NO LEAKAGE OR EXTRA FLUIDS. PUMP WORKED PERFECTLY. SENDING PUMP IN FOR EVALUATION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK