BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOMAT SPACE

    MDR report key: 2621038 · Received June 12, 2012

    Report

    Report Number
    9610825-2012-00082
    Event Type
    Malfunction
    Date Received
    June 12, 2012
    Date of Event
    May 13, 2012
    Report Date
    June 8, 2012
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    FRN
    PMA / PMN Number
    K062700
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(4) (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF B. BRAUN (B)(4) (MFR). (B)(4). THE DEVICE HAS BEEN EVALUATED BY OUR TECHNICAL SERVICE / BBM SALES ORGANIZATION (B)(4). RESULTS: THE DEVICE WAS CHECKED ACCORDING TO SERVICE MANUAL. THE DEVICE IS WORKING WITHIN THE NORMAL PARAMETER. THE PUMP OPERATED AS INTENDED AND THE REPORTED FAILURE COULD NOT BE REPRODUCED. BASED ON THE RESULTS OF THIS INVESTIGATION, NO CONCLUSIONS CAN BE MADE REGARDING THE CAUSE OF THE EVENT.

    Description of Event or Problem · 1

    AS REPORTED BY THE USER FACILITY (TRANSLATION OF USER FACILITY INFO BY (B)(4)): OVERINFUSION: DEVICE IS PROGRAMMED WITH 250CC OF 2 GR DE DIPIRONE + 300 MG PROFENID. TOTAL TIME: 24 HRS AND IT WAS IN 1 HRS.

    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