BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYPUMP 2

    MDR report key: 25280426 · Received May 26, 2026

    Report

    Report Number
    9610825-2026-00268
    Event Type
    Malfunction
    Date Received
    May 26, 2026
    Date of Event
    May 5, 2026
    Report Date
    May 26, 2026
    Manufacturer
    B BRAUN MELSUNGEN AG
    Product Code
    MEB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN INTERNAL REPORT NUMBER (B)(4). BATCH MANUFACTURING RECORD (BMR): REVIEWED THE BMR FOR THE COMPLAINT BATCH 25F26GED81 AND NO ABNORMALITY WAS OBSERVED DURING IN-PROCESS AND FINAL CONTROL INSPECTION. NO SAMPLE AND NO PICTURE WAS RECEIVED FOR FURTHER INVESTIGATION. INVESTIGATION RESULTS: FINAL CONTROL FLOW RATE REPORT OF AFFECTED BATCH 25F26GED81 WAS REVIEWED. FOR FINAL CONTROL FLOW RATE REPORT, THE AVERAGE FLOW RATE DEVIATION FROM THE NOMINAL FLOW RATE WAS BETWEEN 1.36% AND 9.56%. AS NO RETURNED SAMPLE WAS RECEIVED, FURTHER INVESTIGATION WAS NOT POSSIBLE. THERE ARE SOME POSSIBILITIES THAT CAN CAUSE THE SAMPLE TO EMPTY FASTER THAN NOMINAL TIME IN ACTUAL APPLICATION, SUCH AS ONE OR COMBINATION FACTORS OF MORE THAN ONE AS BELOW: FACTOR 1: TEMPERATURE - THE TEMPERATURE OF THE SURROUNDING WILL AFFECT THE FLOW RATE OF THE SAMPLE. FOR EVERY INCREASE OF 1°C, THE FLOW RATE OF THE SAMPLE WILL INCREASE APPROXIMATELY BY 3%. FOR EXAMPLE, IF THE FLOW RESTRICTOR OF THE PRODUCT REACHES THE TEMPERATURE OF 37°C, THE FLOW RATE OF THE SAMPLE WILL INCREASE BY APPROXIMATELY 18% WHICH MEANS THE FLOW RATE WILL INCREASE FROM 2ML/HR TO 2.36ML/HR. FACTOR 2: FOLDED OUTER SHELL (OUTER LAYER) - FOLDED OUTER SHELL (OUTER LAYER) WILL ALSO ACT AS THE EXTERNAL PRESSURE TO ELASTOMERIC MEMBRANE AND INCREASE THE FLOW RATE OF THE PRODUCT. FACTOR 3: EXTERNAL PRESSURE - EXTERNAL PRESSURE SUCH AS SQUEEZING OR LAYING ON THE PUMP WILL INCREASE THE FLOW RATE WHICH CAUSES THE PUMP TO EMPTY EARLIER THAN THE NOMINAL TIME. SIMULATION OF EXTERNAL PRESSURE HAD BEEN CONDUCTED. THE FLOW RATE OF THE PRODUCT CAN INCREASE WHEN EXTERNAL FORCE IS APPLIED TO THE PUMP. HOWEVER, THIS EXTERNAL FORCE IS AGAINST THE INTENDED USE OF THE PRODUCT ACCORDING TO IFU. CONCLUSION: SINCE NO SAMPLE WAS RETURNED THEREFORE FURTHER INVESTIGATION WAS NOT POSSIBLE, HENCE WE CONSIDERED THIS COMPLAINT AS NOT CONFIRMED. PLEASE NOTE, THIS DEVICE IS DISTRIBUTED OUTSIDE THE US AND NO GUDID INFORMATION EXISTS. IT IS BEING REPORTED DUE TO A SIMILAR DEVICE BEING MARKETED WITHIN THE US WITH THE FOLLOWING INFO: UDI NUMBER (B)(4). PREMARKET SUBMISSION # K081905.

    Description of Event or Problem · 0

    ACCORDING TO THE COMPLAINANT: BOTH THE 30-HOUR (60ML) AND 50-HOUR (100ML) INFUSION PUMPS DO NOT INFUSE AT 2ML/HR. THE DEVICE IS PLACED VIA SUBCUTANEOUS ACCESS AND THE EXTENSION IS GLUED TO THE SKIN (AS PER THE MANUFACTURER'S INSTRUCTIONS). WHAT WE HAVE OBSERVED IS THE TERMINATION OF THE MEDICATION INFUSION MANY HOURS EARLIER THAN EXPECTED. THE PATIENTS IN QUESTION DID NOT EXPERIENCE ANY INCREASE IN BODY TEMPERATURE THAT WOULD CAUSE THE INFUSION RATE TO BE FASTER. AS AN EXAMPLE, WE PLACED A 50-HOUR (100ML) INFUSION PUMP IN A PATIENT AT HER HOME ON (B)(6) AT 11:15 AM (WITH 180MG MORPHINE AND 7.5MG MIDAZOLAM). BY 3 PM ON (B)(6), THE DEVICE NO LONGER CONTAINED ANY MEDICATION. IT ONLY INFUSED AT 27H30 INSTEAD OF 50H, WHICH CAUSES AN OVERDOSE OF THERAPY AND AN UNEXPECTED ABSENCE OF IT, WHICH CAUSED THIS PARTICULAR PATIENT TO HAVE UNCONTROLLED PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    439482 EASYPUMP 2 PUMP, INFUSION, ELASTOMERIC MEB B BRAUN MELSUNGEN AG 25F26GED81

    Patients

    Seq Age Sex Outcome Treatment
    1