BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOMAT SPACE - US VERSION

    MDR report key: 3202353 · Received June 18, 2013

    Report

    Report Number
    9610825-2013-00177
    Event Type
    Malfunction
    Date Received
    June 18, 2013
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    FRN
    PMA / PMN Number
    K062700
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). B. BRAUN MEDICAL, INC. (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF B. BRAUN (B)(4). THE ACTUAL PUMP INVOLVED IN THE REPORTED EVENT AND THE PUMP LOGS HAVE NOT BEEN RETURNED FOR EVALUATION. MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION FROM THE FACILITY HAVE NOT BEEN SUCCESSFUL. WITHOUT THE ACTUAL PUMP, PUMP LOGS AND/OR PUMP SERIAL NUMBER, A THOROUGH INVESTIGATION COULD NOT BE PERFORMED AND NO SPECIFIC CONCLUSIONS CAN BE DRAWN AS TO THE CAUSE OF THE REPORTED EVENT. IF THE PUMP, PUMP LOGS AND/OR ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    276288 INFUSOMAT SPACE - US VERSION INFUSION PUMP FRN B. BRAUN MELSUNGEN AG

    Patients

    Seq Age Sex Outcome Treatment
    1