BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOMAT SPACE

    MDR report key: 2840033 · Received November 15, 2012

    Report

    Report Number
    9610825-2012-00236
    Event Type
    Malfunction
    Date Received
    November 15, 2012
    Report Date
    November 15, 2012
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    FRN
    PMA / PMN Number
    K062700
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EXEMPTION NUMBER (B)(4). B. BRAUN MEDICAL, INC. (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF B. BRAUN (B)(4) (MANUFACTURER). THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN (B)(4). THE DEVICE IS CURRENTLY SHIPPING FROM (B)(6) TO BBM LABORATORY IN (B)(4) FOR INVESTIGATION. A FOLLOW-UP REPORT WILL BE PROVIDED AFTER THE INSPECTION RESULTS ARE AVAILABLE.

    Description of Event or Problem · 1

    AS REPORTED BY THE USER FACILITY (TRANSLATION OF USER FACILITY INFORMATION BY BBM SALES ORGANIZATION IN (B)(4)): PUMP DELIVERS TOO SLOWLY: ACCORDING TO THE WARD, THE PUMP DELIVERS SLOWER THAN THE RATE SET IN THE PUMP.

    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