BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYPUMP®

    MDR report key: 23657240 · Received November 26, 2025

    Report

    Report Number
    9610825-2025-00697
    Event Type
    Malfunction
    Date Received
    November 26, 2025
    Report Date
    December 2, 2025
    Manufacturer
    B BRAUN MELSUNGEN AG
    Product Code
    MEB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INTERNAL REPORT NUMBER (B)(4). THE INVESTIGATION IS ONGOING AT THIS TIME. A FOLLOW- UP WILL BE SUBMITTED WHEN THE INVESTIGATION RESULTS BECOME AVAILABLE. NOTE: THIS REPORTED IS BEING FILED FOR AN ITEM NUMBER THAT IS NOT SOLD IN THE UNITED STATES, HOWEVER SIMILAR ITEMS ARE SOLD IN THE UNITED STATES BY B. BRAUN MEDICAL, INC. 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: PREMARKET SUBMISSION # K081905.

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INTERNAL REPORT NUMBER (B)(4). DEVICE HISTORY RECORD (DHR): REVIEWED THE DHR FOR BATCH 23D05GEE31, THERE IS NO ABNORMALITY AND NO SUCH DEFECT DETECTED AT IN PROCESS AND FINAL CONTROL INSPECTION. SAMPLE EVALUATION: RECEIVED ONE SAMPLE OF EASYPUMP II LT 270-135-S-EU/SA WITHOUT ORIGINAL PACKAGING. THE BATCH NUMBER ON THE BIG BOTTOM CAP OF THE SAMPLE WAS 23D05GEE31. INVESTIGATION RESULTS: THE FLOW RATE REPORT OF AFFECTED BATCH 23D05GEE31 WAS REVIEWED. FOR FINAL CONTROL FLOW RATE REPORT, THE AVERAGE FLOW RATE DEVIATION FROM THE NOMINAL FLOW RATE WAS BETWEEN -0.85% AND 4.85%. THE RECEIVED SAMPLE WAS WEIGHED AND RECORDED AT 78.57G. AN UNFILLED EASYPUMP FOR THIS ARTICLE TYPICALLY WEIGHS 75G, AND THE RETAINED VOLUME SHOULD BE 3G. THIS INDICATES THAT THE RECEIVED SAMPLE WAS EMPTIED. THE SAMPLE WAS DECONTAMINATED AND SENT FOR FLOW RATE TEST. THE FLOW RATE DEVIATION FROM NOMINAL FLOW RATE FOR RECEIVED SAMPLE WAS 0.45%. THE FLOW RATE OF RECEIVED SAMPLE WAS WITHIN THE SPECIFICATION ±15% DEVIATION FROM NOMINAL FLOW RATE. HOWEVER, 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 2 ML/HR TO 2.36ML/HR. FACTOR 2: EXTERNAL PRESSURE EXTERNAL PRESSURE SUCH AS SQUEEZING OR LAYING ON THE PUMP WILL INCREASE THE FLOW RATE WHICH CAUSE 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. FACTOR 3: FOLDER OUTER SHELL ACCORDING TO IFU, THE OUTER LAYER HAS TO BE UNFOLDED PROPERLY PRIOR FILLING. FOLDED OUTER SHELL WILL ACT AS THE EXTERNAL PRESSURE TO ELASTOMERIC MEMBRANE AND INCREASE THE FLOW RATE OF THE PRODUCT. CONCLUSION: SINCE THE FLOW RATE OF RECEIVED SAMPLE WAS WITHIN THE SPECIFICATION, HENCE WE CONSIDERED THIS COMPLAINT AS NOT CONFIRMED. NOTE: THIS REPORT IS BEING FILED FOR AN ITEM NUMBER THAT IS NOT SOLD IN THE UNITED STATES, HOWEVER SIMILAR ITEMS ARE SOLD IN THE UNITED STATES BY B. BRAUN MEDICAL, INC.

    Description of Event or Problem · 0

    ACCORDING TO THE EVENT DESCRIPTION: "THE PUMP WAS FILLED WITH 192ML KETAMIN AND RAN WITH 2ML/H. THE PUMP WAS EMPTY AFTER 3DAYS, NOT 4 DAYS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    131399 EASYPUMP® PUMP, INFUSION, ELASTOMERIC MEB B BRAUN MELSUNGEN AG 23D05GEE31

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown