BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERFUSOR SPACE ACM-KIT

    MDR report key: 5905138 · Received August 25, 2016

    Report

    Report Number
    9610825-2016-00581
    Event Type
    Malfunction
    Date Received
    August 25, 2016
    Report Date
    August 5, 2016
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    FRN
    PMA / PMN Number
    K062699
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    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 DEVICE INVOLVED HAS BEEN RECEIVED FOR EVALUATION AND THE INVESTIGATION IS ONGOING AT THIS TIME. A FOLLOW UP WILL BE SUBMITTED WHEN THE INVESTIGATION RESULTS BECOME 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 50ML/HR AND 5ML AND 60ML SYRINGE. THE TEST RESULTS WERE WITHIN SPECIFICATIONS. THE PUMP'S OPERATIONAL LOG WAS REVIEWED AND THERE WERE NO INDICATION THAT THE PUMP MALFUNCTIONED. 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 USER FACILITY: REF # 8713080U SERIAL # (B)(6). REPORTS OVER INFUSION: GAVE 6 DOSES OF MORPHINE WITHOUT BOLUS BUTTON BEING PUSHED. PUMP IS BEING RETURNED. LIMITED INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    556219 PERFUSOR SPACE ACM-KIT SYRINGE PUMP FRN B. BRAUN MELSUNGEN AG

    Patients

    Seq Age Sex Outcome Treatment
    1