BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OUTLOOK ES

    MDR report key: 3043030 · Received March 7, 2013

    Report

    Report Number
    1641965-2013-00003
    Event Type
    Malfunction
    Date Received
    March 7, 2013
    Date of Event
    February 13, 2013
    Report Date
    February 20, 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
    NY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED COMPLAINT WAS CONFIRMED. THE DEVICE WAS EVALUATED AND REPAIRED AT THE CUSTOMER'S FACILITY BY A B. BRAUN FIELD SVC TECH. THE MAIN BOARD (PCB) WAS DEFECTIVE AND CAUSED THE ISSUE. THE MAIN BOARD WAS REPLACED. THE CUSTOMER NOTIFIED THE FIELD SVC TECH THE PUMP WAS NOT FUNCTIONING PRIOR TO INITIATING THE COMPLAINT, AND THE TECH COMPLETED THE FIELD SVC REPAIR ON (B)(4) 2013, PER SVC/REPAIR PROCEDURES, PRIOR TO THE CUSTOMER INITIATING THE COMPLAINT ON (B)(6) 2013. A REVIEW OF THIS DEVICE'S MFG AND SVC HISTORY INDICATES NO FAILURE DURING THE MANUFACTURE OF THIS DEVICE, AND NO FAILURE AFTER THE DEVICE WAS SHIPPED, UNTIL AND INCLUDING THIS COMPLAINT. B. BRAUN COMPLETED THE EVAL, REPAIR, AND FINAL TESTING OF THIS DEVICE PER THE SVC/REPAIR PROCEDURES. THE DEVICE MET ALL TESTING REQUIREMENTS.

    Description of Event or Problem · 1

    WHILE INFUSING, PUMP STOPPED INFUSING WITHOUT ALARM SOUNDING. INFUSING INSULIN AT THE TIME. NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98363 OUTLOOK ES INFUSION PUMP FRN B. BRAUN MEDICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention