BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOMAT SPACE ACM-KIT

    MDR report key: 5844932 · Received August 3, 2016

    Report

    Report Number
    9610825-2016-00538
    Event Type
    Malfunction
    Date Received
    August 3, 2016
    Report Date
    July 25, 2016
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    FRN
    PMA / PMN Number
    K062700
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2011009. B. BRAUN MEDICAL INC. (THE IMPORTER) IS SUBMITTING A SINGLE REPORT ON BEHALF OF B. BRAUN MELSUNGEN (THE MANUFACTURER). THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INC. INTERNAL REPORT# (B)(4). THE ACTUAL DEVICE INVOLVED HAS NOT BEEN RECEIVED FOR EVALUATION AND THE INVESTIGATION IS ONGOING AT THIS TIME. A FOLLOW UP REPORT WILL BE PROVIDED AFTER THE EXAMINATION RESULTS ARE AVAILABLE.

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2011009. B. BRAUN MEDICAL INC. IS SUBMITTING A SINGLE REPORT ON BEHALF OF B. BRAUN MELSUNGEN (THE MANUFACTURER), AND B. BRAUN MEDICAL INC. (THE IMPORTER). THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INTERNAL REPORT NUMBER (B)(4). THE VOLUMETRIC ACCURACY WAS TESTED THREE TIMES AT A RATE OF 250ML/HR AND A VOLUME TO BE INFUSED OF 25ML. THE TEST RESULTS WERE WITHIN SPECIFICATIONS. BASED ON THE RESULTS OF THE INVESTIGATION, THE PUMP OPERATED AS INTENDED. IF ADDITIONAL PERTINENT INFORMATION BECOMES AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    AS REPORTED BY THE FACILITY: THE CUSTOMER REPORTED : UNDER INFUSION. NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    495104 INFUSOMAT SPACE ACM-KIT INFUSION PUMP FRN B. BRAUN MELSUNGEN AG

    Patients

    Seq Age Sex Outcome Treatment
    1