BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYPUMP 2

    MDR report key: 18766409 · Received February 23, 2024

    Report

    Report Number
    9610825-2024-00096
    Event Type
    Malfunction
    Date Received
    February 23, 2024
    Report Date
    June 7, 2024
    Manufacturer
    B BRAUN MELSUNGEN AG
    Product Code
    MEB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    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). 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.

    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 ITEMS ARE SOLD IN THE UNITED STATES BY B. BRAUN MEDICAL, INC. UPDATED INFORMATION: D9 DATE RETURNED TO MANUFACTURER. H6 CODES UPDATED. ROOT CAUSE ANALYSIS: RECEIVED 1 SAMPLE WITHOUT ORIGINAL PACKAGING. THE BATCH NUMBER ON THE BBC (BIG BOTTOM CAP) OF THE COMPLAINT IS (B)(4). THE COMPLAINT SAMPLE WAS FILLED WITH SOLUTION AND BBC WAS REMOVED. LEAKAGE WAS OBSERVED AT TRIANGLE TUBE TO STEP DOW TUBE CONNECTION. AN APPROVED PROJECT HAD BEEN RAISED TO ADDRESS TRIANGLE TUBE TO STEP DOWN TUBE CONNECTION LEAKAGE ISSUE. SUMMARY OF ROOT CAUSE ANALYSIS: THE COMPLAINT SAMPLE WAS LEAKING AT TRIANGLE TUBE TO STEP DOWN TUBE CONNECTION. THUS, WE CONSIDERED THIS COMPLAINT AS CONFIRMED. CAUSE: FAILURE IN PRODUCTION PROCESS CORRECTIONS/CONTAINMENT PLANS WITH EFFECTIVE DATE: NOT APPLICABLE. JUSTIFICATION: CONFIRMED.

    Description of Event or Problem · 0

    AS REPORTED BY THE USER FACILITY INFORMATION BY BBM SALES ORGANIZATION IN ITALY: "CHEMO LEAKAGE". ACCORDING TO THE CUSTOMER: THE CUSTOMER HAS DETECTED A LEAK OF THE SOLUTION INTRODUCED INTO THE ELASTOMER. THE POINT WHERE THE SOLUTION LEAKS IS WHERE THE TUBE IS INSERTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    228859 EASYPUMP 2 ELASTOMERIC PUMPS MEB B BRAUN MELSUNGEN AG 4540016-07 23B06GED81

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown