BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOMAT SPACE - US VERSION

    MDR report key: 2949539 · Received February 5, 2013

    Report

    Report Number
    9610825-2013-00009
    Event Type
    Malfunction
    Date Received
    February 5, 2013
    Date of Event
    December 25, 2012
    Report Date
    January 7, 2013
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    FRN
    PMA / PMN Number
    K062700
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). B. BRAUN MEDICAL INC. IS SUBMITTING A SINGLE REPORT ON BEHALF OF (B)(4). THE ACTUAL DEVICE INVOLVED IN THE REPORTED EVENT HAS BEEN REC'D FOR EVAL. THE INVESTIGATION ON THE DEVICE IS ONGOING AT THIS TIME. A F/U REPORT WILL BE PROVIDED AFTER THE INSPECTION RESULTS ARE AVAILABLE. THE PUMP HAS SOFTWARE VERSION (B)(4).

    Description of Event or Problem · 1

    AS REPORTED BY THE USER FACILITY: REF# (B)(4) - SERIAL# (B)(4). OVER INFUSION FREE FLOW. THE CUSTOMER STATED THAT THEY NOTICED THE FREE FLOW CLAMPED OFF TUBING AND STOPPED THE PUMP. THE HOOK UP WAS CHECKED BY 2 NURSES. OPENED THE CLAMP AGAIN AND FREE FLOW OCCURRED AGAIN. THE 150CC OF THIS FLUID WAS INFUSED INTO THE PT. STAFF THOUGH THIS WAS A TUBING ISSUE HOWEVER THEY DIDN'T SAVE THE TUBING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    48158 INFUSOMAT SPACE - US VERSION INFUSION PUMP FRN B. BRAUN MELSUNGEN AG NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other