BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYPUMP II

    MDR report key: 18102632 · Received November 9, 2023

    Report

    Report Number
    9610825-2023-00079
    Event Type
    Malfunction
    Date Received
    November 9, 2023
    Report Date
    November 9, 2023
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    MEB
    PMA / PMN Number
    K062700
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MELSUNGEN AG INTERNAL REPORT # (B)(4). SAMPLE FOR EVALUATION: WE RECEIVED ONE SAMPLE OF EASYPUMP II LT 100-50-S WITHOUT ORIGINAL PACKAGING. THE BATCH NUMBER ON THE BIG BOTTOM CAP OF THE SAMPLE WAS 22F29GE26R. UPON RECEIPT, NO SOLUTION WAS FOUND IN THE PUMP AND THE SAMPLE WAS CLAMPED. HOWEVER, CLEAR SOLUTION WAS FOUND INSIDE THE RETURNED PACKAGING SOAKING THE SAMPLE. LEAKAGE TEST: UPON FILLING SOLUTION INTO THE PUMP, LEAKAGE WAS DETECTED AT THE TRIANGLE TUBE TO STEP DOWN TUBE (SDT) CONNECTION. THIS DEFECT IS KNOWN AND ALREADY ADDRESSED IN CAPA. ROOT CAUSES WERE IDENTIFIED AND RECTIFIED. 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.

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MELSUNGEN AG INTERNAL REPORT (B)(4). THE COMPLAINT IS UNDER EVALUATION. 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 ITEMS ARE SOLD IN THE UNITED STATES BY B. BRAUN MEDICAL, INC.

    Description of Event or Problem · 0

    AS REPORTED BY THE USER FACILITY (TRANSLATION OF USER FACILITY INFORMATION BY BBM SALES ORGANIZATION IN SINGAPORE: "CHEMO LEAKAGE". ACCORDING TO THE CUSOMER: "EASYPUMP LEAKING."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1866734 EASYPUMP II ELASTOMERIC INFUSION PUMP MEB B. BRAUN MELSUNGEN AG 22F29GE26R

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown