BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYPUMP® II

    MDR report key: 7351070 · Received March 19, 2018

    Report

    Report Number
    9610825-2018-00046
    Event Type
    Malfunction
    Date Received
    March 19, 2018
    Date of Event
    November 23, 2017
    Report Date
    March 19, 2018
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    MEB
    UDI-DI
    04046964448638
    PMA / PMN Number
    K081905
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2016018 B. BRAUN MEDICAL, INC. (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF B. BRAUN MELSUNGEN AG (MANUFACTURER). THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MELSUNGEN AG INTERNAL REPORT # (B)(4). WE RECEIVED ONE USED AND EMPTY EASYPUMP II LT 270-54-S WITHOUT PACKAGING. THE RETURNED SAMPLE WAS TAKEN TO A VISUAL INSPECTION. AS-RECEIVED CONDITION THE WHITE CLAMP WAS CLOSED AND THE PATIENT CONNECTOR WAS NOT CLOSED, THE ORIGINAL WING CAP WAS NOT HANDED OVER BY THE CUSTOMER. DAMAGES THAT WOULD LEAD TO A MALFUNCTION WERE NOT DETECTED AT THE RECEIVED SAMPLE. AFTER OPENING THE BIG TOP CAP WE DETECTED SOLUTION (LIQUID) AT THE FILLING PORT (LLI-CONE). WE DETECTED NO SOLUTION (LIQUID) AT THE PATIENT CONNECTOR. IN ADDITION, THE SAMPLE WAS TAKEN TO A FUNCTIONAL TEST RESPECTIVELY A LEAK TEST WAS CARRIED OUT. THEREFORE THE PUMP WAS FILLED UP TO THE NOMINAL VOLUME OF 270 ML WITH NACL 0.9 %. AFTER STARTING THE PUMP (OPENING THE WHITE CLAMP) AND WAITING FOR 60 MINUTES THE PUMP IS WORKING IMMEDIATELY (SOLUTION WAS RUNNING). LEAKAGES WERE NOT DETECTED. THE VALUE OF THE MEASURED FLOW RATE IS WITHIN OUR SPECIFICATION AT THE TESTED SAMPLE. A TOO FAST FLOW (AS DESCRIBED BY THE CUSTOMER) COULD NOT BE DETERMINED AT THE RECEIVED SAMPLE. DEVICE HISTORY RECORD (DHR): REVIEWED THE DHR AND NO ABNORMALITY OBSERVED DURING IN-PROCESS AND AT FINAL CONTROL INSPECTION.

    Description of Event or Problem · 0

    AS REPORTED BY THE USER FACILITY (TRANSLATION OF USER FACILITY INFORMATION BY BBM SALES ORGANIZATION IN BRAZIL: INFUSION FASTER

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    190900 EASYPUMP® II ELASTOMERIC INFUSION PUMP MEB B. BRAUN MELSUNGEN AG N/A 16K02GE271 04046964448638

    Patients

    Seq Age Sex Outcome Treatment
    1