BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOMAT SPACE - US VERSION

    MDR report key: 4417985 · Received January 5, 2015

    Report

    Report Number
    9610825-2014-00469
    Event Type
    Malfunction
    Date Received
    January 5, 2015
    Date of Event
    December 16, 2014
    Report Date
    December 16, 2014
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    FPA
    PMA / PMN Number
    K062700
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN (B)(4). THE ACTUAL DEVICE HAS BEEN RECEIVED AND THE INVESTIGATION IS ON GOING AT THIS TIME. A FOLLOW UP REPORT WILL BE PROVIDED WHEN THE INVESTIGATION RESULTS BECOME AVAILABLE. IMPORTER REFERENCE#: 2523676-2014-0000469.

    Description of Event or Problem · 1

    AS REPORTED BY THE USER FACILITY: EVENT DESCRIPTION: PATIENT WAS STARTED ON A CARDENE GTTS FOR HYPERTENSION CONTROL AT 2100. MEDICATION WAS TITRATED UP TO A MAX DOSE OF 12.5 MG/HR TO KEEP BLOOD PRESSURE DOWN. WHEN CHANGING ANOTHER IV FLUID BAG, IT WAS NOTED THAT THE CARDENE BAG STILL HAD A LARGE AMOUNT OF FLUID IN IT. ACCORDING TO THE IV PUMP, IT SHOULD HAVE INFUSED 170 CCS OF THE 200 CCS IN THE BAG. THE BAG STILL HAD MORE THAN 100 CCS OF FLUID IN IT. WHEN THE IV PUMP WAS CHANGED, CONTROL OF HYPERTENSION WAS OBTAINED AT ONLY 5 MG/HR. NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    3633 INFUSOMAT SPACE - US VERSION INFUSION PUMP FPA B. BRAUN MELSUNGEN AG NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN