BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYPUMP

    MDR report key: 22203032 · Received June 13, 2025

    Report

    Report Number
    9610825-2025-00322
    Event Type
    Malfunction
    Date Received
    June 13, 2025
    Report Date
    July 2, 2025
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    MEB
    UDI-DI
    04046964448638
    PMA / PMN Number
    K081905
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    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). EVENT 1: ONE (1) SAMPLE WITH THE LOT NUMBER 24K08GE561 WAS SUBMITTED TO THE MANUFACTURER FOR EVALUATION. THROUGH VISUAL EXAMINATION OF THE SAMPLE, THE FILLING PORT OF THE SAMPLE WAS OBSERVED TO HAD BEEN CONNECTED TO A LUER LOCK ADAPTOR WITH SYRINGE. SOME CLEAR SOLUTION WAS FOUND INSIDE THE 60 ML SYRINGE. AFTER REMOVING THE ADAPTOR FROM THE FILLING PORT, CRACKS WERE OBSERVED AT THE FILLING PORT OF THE SAMPLE. THE SAMPLE WAS FILLED WITH RED DYE SOLUTION TO CHECK FOR LEAKAGE. LEAKAGE WAS OBSERVED FROM THE CRACK FILLING PORT DURING THE FILLING PROCESS. THE REPORTED DEFECT IS CONFIRMED. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED FOR THE REPORTED LOT NUMBERS AND NO ABNORMALITIES OR NON-CONFORMANCES WERE NOTED DURING THE IN PROCESS OR FINAL PRODUCT INSPECTION. THE ASSEMBLY PROCESS FLOW OF EASYPUMP II WAS REVIEWED AND ANALYZED TO DETERMINE THE POTENTIAL ROOT CAUSE. BASED ON THE ANALYSIS CONDUCTED, CRACK AT FILLING PORT COULD BE RULED OUT FROM ASSEMBLY AREA. WHILE A DEFECT WAS OBSERVED, AN EXACT ROOT CAUSE COULD NOT BE DETERMINED. FURTHER ENGINEERING STUDY WILL BE CONDUCTED TO EVALUATE THE STRESS ANALYSIS ON THE CAP VALVE; FURTHER ACTION WILL BE IMPLEMENTED BASED ON THE RESULTS. WE WILL MAINTAIN THIS REPORT FOR FURTHER REFERENCES AND CONTINUE TO MONITOR OTHER REPORTS FOR SIMILAR OCCURRENCES. IF ANY ADDITIONAL PERTINENT INFORMATION BECOMES AVAILABLE, A FOLLOW UP WILL BE SUBMITTED.

    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.

    Description of Event or Problem · 0

    AS REPORTED BY THE USER FACILITY: EVENT 1 WE RECENTLY STARTED USING THE ELASTOMERIC EASYPUMP FOR 5FU INFUSIONS. WE HAVE HAD A FEW INSTANCES OF THE BALL LEAKING PART WAY INTO THE FILLING PROCESS. I WOULD LIKE TO DISCUSS OUR PROCESS WITH SOMEONE. SAME DEVICE, SAME USER OBSERVED BY TEAM MEMBERS. OCCURRED UNDER THE HOOD. PUMP IS CONNECTED TO EQUASHIELD LUER LOCK CSTD. USER STATES PUMP IS SUPPORTED DURING THE FILLING PROCESS TO PREVENT PORT CRACKING, LUER DEVICES DO NOT APPEAR OVERTIGHTENED.? UNSURE IF LEAKAGE COMES FROM NECK OF THE BALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    354047 EASYPUMP PUMP, INFUSION, ELASTOMERIC MEB B. BRAUN MELSUNGEN AG 24K08GE561 04046964448638

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown