BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYPUMP 2

    MDR report key: 21762656 · Received April 3, 2025

    Report

    Report Number
    9610825-2025-00195
    Event Type
    Malfunction
    Date Received
    April 3, 2025
    Date of Event
    March 6, 2025
    Report Date
    April 22, 2025
    Manufacturer
    B BRAUN MELSUNGEN AG
    Product Code
    MEB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RO
    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). NOTE: THIS REPORT IS BEING FILED FOR AN ITEM NUMBER THAT IS NOT SOLD IN THE UNITED STATES, HOWEVER SIMILAR DEVICES ARE SOLD IN THE UNITED STATES BY B. BRAUN MEDICAL, INC. PRIMARY UNIQUE DEVICE IDENTIFIER (UDI) # FOR SIMILAR DEVICE: UDI NUMBER: (B)(4). PREMARKET SUBMISSION # K081905. DEVICE HISTORY RECORD (DHR): REVIEWED THE DHR FOR BATCH 24H26GED91, THERE WAS NO DEFECT ENCOUNTERED DURING IN PROCESS AND FINAL CONTROL INSPECTION. SAMPLE EVALUATION: RECEIVED ONE SAMPLE OF EASYPUMP II LT 270-54-S-EU/SA WITHOUT ORIGINAL PACKAGING. THE BATCH NUMBER ON THE BIG BOTTOM CAP OF THE SAMPLE WAS 24H26GED91. INVESTIGATION RESULTS: PRELIMINARY INVESTIGATION OBSERVED WHITE CRYSTALLIZATION AROUND THE FILTER WELDED AREA. DYE SOLUTION WAS ALLOWED TO PASS THROUGH THE FILTER FOR BETTER OBSERVATION. THE SOLUTION WAS LEAKING OUT FROM THE WELDED AREA OF THE FILTER. CONCLUSION: FILTER LEAK WAS OBSERVED FROM THE RETURNED COMPLAINT SAMPLE. HENCE, THIS COMPLAINT IS CONSIDERED AS CONFIRMED. FILTER IS A PURCHASED COMPONENT, AND THUS SUPPLIER WAS NOTIFIED FOR FURTHER INVESTIGATION AND NECESSARY ACTION.

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN INTERNAL REPORT NUMBER (B)(4). A FOLLOW-UP REPORT WILL BE PROVIDED AFTER THE EXAMINATION RESULTS ARE AVAILABLE. NOTE: THIS REPORT IS BEING FILED FOR AN ITEM NUMBER THAT IS NOT SOLD IN THE UNITED STATES, HOWEVER SIMILAR DEVICES ARE SOLD IN THE UNITED STATES BY B. BRAUN MEDICAL, INC. PRIMARY UNIQUE DEVICE IDENTIFIER (UDI) # FOR SIMILAR DEVICE: UDI NUMBER: (B)(4). PREMARKET SUBMISSION # K081905.

    Description of Event or Problem · 0

    ACCORDING TO THE CUSTOMER: "THE PUMP WAS FILLED WITH 5FU AND CALCIUM FOLINATE. IMMEDIATELY AFTER INSTALLATION ON THE PATIENT, THE SOLUTION BEGAN TO FLOW AND WET THE PATIENT'S BLOUSE. THE SOLUTION LEAKAGE OCCURS THROUGH THE FILTER ATTACHED TO THE TUBE. THE ADMINISTRATION WAS INTERRUPTED IMMEDIATELY. THE PATIENT RECEIVED ANOTHER PUMP FOR TREATMENT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    575074 EASYPUMP 2 PUMP, INFUSION, ELASTOMERIC MEB B BRAUN MELSUNGEN AG 4540018-07 24H26GED91

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown