BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOMAT SPACE - US VERSION

    MDR report key: 4071948 · Received August 25, 2014

    Report

    Report Number
    9610825-2014-00311
    Event Type
    Malfunction
    Date Received
    August 25, 2014
    Date of Event
    July 25, 2014
    Report Date
    August 6, 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
    ME, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). B. BRAUN MED INC IS SUBMITTING A SINGLE REPORT ON BEHALF OF B. BRAUN (B)(4) (THE MFR) AND B. BRAUN MED INC. (THE IMPORTER). THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN (B)(4). THE ACTUAL DEVICE INVOLVED HAS BEEN RECEIVED AND THE INVESTIGATION IS ONGOING AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION RESULTS BECOME AVAILABLE.

    Description of Event or Problem · 1

    AS REPORTED BY THE USER FACILITY: OVER INFUSION: EVENT REPORTED BY BIOMED. BIOMED STATES "THAT THE PUMP WAS PROGRAMMED TO GIVE NORMAL BOLUS OF NACL IN 500ML BAG. NURSE RETURNED IN 1 HR TO FIND THE BAG EMPTY. IT IS UNK AT THIS TIME WHAT THE BOLUS RATE WAS SET TO OR THE PRIMARY RATE. THERE WAS NO HARM TO THE PT." NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    511102 INFUSOMAT SPACE - US VERSION INFUSION PUMPS FPA B. BRAUN MELSUNGEN AG NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK