BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYPUMP

    MDR report key: 7868260 · Received September 12, 2018

    Report

    Report Number
    9610825-2018-00189
    Event Type
    Malfunction
    Date Received
    September 12, 2018
    Report Date
    October 31, 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
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE 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 THREE OF B. BRAUN MEDICAL INC. INTERNAL REPORT NUMBER (B)(4). THE INVESTIGATION INTO THIS REPORTED EVENT IS ONGOING. ADDITIONAL ATTEMPTS TO RECEIVE SAMPLES ARE BEING MADE. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE RESULTS OF THE INVESTIGATION ARE AVAILABLE.

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2016018. (B)(4) (IMPORTER) IS SUBMITTING THE REPORT ON BEHALF OF B. BRAUN MELSUNGEN AG (MANUFACTURER). THIS REPORT HAS BEEN IDENTIFIED AS EVENT THREE OF (B)(4) INTERNAL REPORT NUMBER (B)(4). THE ACTUAL DEVICE INVOLVED IN THE REPORTED INCIDENT WAS NOT RETURNED FOR EVALUATION. WITHOUT THE ACTUAL SAMPLE OR A REPORTED BATCH A THOROUGH ROOT CAUSE ANALYSIS COULD NOT BE PERFORMED AND NO SPECIFIC CONCLUSIONS CAN BE DRAWN. ALTHOUGH SAMPLES WEREN'T RECEIVED, THE IFU FOR THE PRODUCT DOES SPEAK TO SOME POSSIBILITIES THAT COULD CAUSE THE PUMP TO EMPTY FASTER THAN THE NOMINAL TIME: POSSIBILITY 1: THE TEMPERATURE OF THE SURROUNDING WILL AFFECT THE FLOW RATE OF THE PUMP. FOR EVERY INCREASE OF 1°C, THE FLOW RATE OF THE PUMP WILL INCREASE BY APPROXIMATELY 3%. FOR EXAMPLE, IF THE FLOW RESTRICTOR OF THE PRODUCT REACHES THE TEMPERATURE OF 37°C, THE FLOW RATE OF THE PUMP WILL INCREASE BY APPROXIMATELY 18%, WHICH MEANS THAT THE FLOW RATE WOULD INCREASE FROM 5ML/HR TO APPROXIMATELY 6ML/HR. POSSIBILITY 2: EXTERNAL PRESSURE SUCH AS SQUEEZING OR LAYING ON THE PUMP WILL INCREASE THE FLOW RATE. 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 3: EASYPUMP 5 ML/HR - 270 ML FILLED WITH NS AND 5FU TO 230/240 ML RAN OVER 12 HRS INSTEAD OF 46 HRS. FLOW RESTRICTOR WAS TAPED TO THE PATIENT'S SKIN. THE PATIENT WAS VERY ACTIVE AND THE REGION WAS EXPERIENCING A HEAT WAVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    709559 EASYPUMP PUMP, INFUSION, ELASTOMERIC MEB B. BRAUN MELSUNGEN AG UNKNOWN 04046964448638

    Patients

    Seq Age Sex Outcome Treatment
    1