BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYPUMP

    MDR report key: 7503970 · Received May 10, 2018

    Report

    Report Number
    9610825-2018-00082
    Event Type
    Malfunction
    Date Received
    May 10, 2018
    Report Date
    June 14, 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
    MA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2016018 B. BRAUN INC. (BBMI) (IMPORTER) IS SUBMITTING THE REPORT ON BEHALF OF B. BRAUN MELSUNGEN AG (MANUFACTURER). THIS REPORT HAS BEEN IDENTIFIED AS EVENT TWO OF B. BRAUN MEDICAL INC. INTERNAL REPORT NUMBER (B)(4). THE INVESTIGATION INTO THIS REPORTED EVENT IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE RESULTS OF THE INVESTIGATION ARE AVAILABLE.

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2016018. (B)(4). TWO (2) USED DEVICES WERE RECEIVED FOR EVALUATION. THE FLOW RATE OF BOTH DEVICES WAS CHECKED OVER THE COURSE OF 28 HOURS, AND BOTH PUMPS WERE WITHIN SPECIFICATION. NO ADVERSE QUALITY TRENDS OF THIS NATURE WERE IDENTIFIED DURING THE COMPLAINT REVIEW PROCESS FOR THE REPORTED CATALOG NUMBER. BASED ON THE RESULTS OF THIS INVESTIGATION, NO SPECIFIC CONCLUSIONS CAN BE MADE REGARDING THE CAUSE OF THE REPORTED EVENT. THE RETURNED DEVICE MET REQUIREMENTS ACCORDING TO SPECIFICATION, AND THE REPORTED FAILURE COULD NOT BE REPRODUCED. ALTHOUGH THE CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED, IT SHOULD BE NOTED THAT THE IFU FOR THE PRODUCT DOES INDICATE THAT THE TEMPERATURE OF THE SURROUNDING ENVIRONMENT WILL AFFECT THE FLOW RATE OF THE DEVICE, AND FOR EVERY INCREASE OF 1 DEGREE CELSIUS THE FLOW RATE WILL INCREASE BY APPROXIMATELY 3%. THE IFU ALSO INDICATES THAT THE FLOW RESTRICTOR OF THE PRODUCT MUST BE TAPED TO THE PATIENT'S SKIN IN ORDER TO HAVE PROPER FLOW. IF ADDITIONAL PERTINENT INFORMATION BECOMES AVAILABLE A FOLLOW-UP REPORT WILL BE FILED.

    Description of Event or Problem · 0

    AS REPORTED BY USER FACILITY: EVENT 2; THE INFUSION RATE IS SUPPOSED TO BE 48 TO 54 HOURS, BUT IT IS ONLY LASTING 36 HOURS. NO PATIENT INVOLVEMENT, THE END CUSTOMER PERFORMED A SELF TEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    344362 EASYPUMP PUMP, INFUSION, ELASTOMERIC MEB B. BRAUN MELSUNGEN AG 16H02GE56R 04046964448638

    Patients

    Seq Age Sex Outcome Treatment
    1