BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERFUSON SPACER

    MDR report key: 2974111 · Received February 15, 2013

    Report

    Report Number
    9610825-2013-00011
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Date of Event
    January 23, 2013
    Report Date
    January 25, 2013
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    FRN
    PMA / PMN Number
    K062699
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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 DEVICE INVOLVED IN THE EVENT HAS BEEN RECEIVED IN (B)(4) AND THE INVESTIGATION IS ON-GOING AT THIS TIME. 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 INFO BY BBM (B)(4)): SWITCHED OFF WITHOUT ALARM DURING RUN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69381 PERFUSON SPACER INFUSION SYRINGE PUMP FRN B. BRAUN MELSUNGEN AG NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other