BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOMAT SPACE

    MDR report key: 2850244 · Received October 12, 2012

    Report

    Report Number
    9610825-2012-00203
    Event Type
    Malfunction
    Date Received
    October 12, 2012
    Date of Event
    September 20, 2012
    Report Date
    October 12, 2012
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    FRN
    PMA / PMN Number
    K062700
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EXEMPTION NUMBER (B)(4). B. BRAUN MEDICAL, INC. (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF B. BRAUN (B)(4). THE DEVICE IS CURRENTLY SHIPPING FROM (B)(6) TO BBM LABORATORY IN (B)(4) FOR INVESTIGATION. A FOLLOW-UP REPORT WILL BE PROVIDED AFTER THE INSPECTION RESULTS ARE AVAILABLE.

    Description of Event or Problem · 1

    AS REPORTED BY THE USER FACILITY (TRANSLATION OF USER FACILITY INFORMATION BY BBM SALES ORGANIZATION IN (B)(4)): THE PT WAS ADMINISTERED AN INFUSION BY THIS RESPECTIVE INFUSOMAT SPACE PUMP AT THE RATE OF 10 ML/H IN ABOUT 2 HOURS. SUDDENLY THE PUMP GAVE THE ALARM "TOO MANY DROPS" AND A FREE FLOW SITUATION WAS NOTICED, DESPITE THAT THE INFUSION WAS DISRUPTED BY PRESSING THE "STOP" BUTTON. THE PUMP WAS CHANGED TO ANOTHER WHERE AFTER NO PROBLEMS OCCURRED. THE INFUSION WAS SALINE SO THE PT WAS NOT EXPOSED TO HAZARD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFUSOMAT SPACE INFUSION PUMP FRN B. BRAUN MELSUNGEN AG NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other