BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYPUMP 2

    MDR report key: 18477168 · Received January 9, 2024

    Report

    Report Number
    9610825-2023-00676
    Event Type
    Malfunction
    Date Received
    January 9, 2024
    Date of Event
    December 11, 2023
    Report Date
    April 12, 2024
    Manufacturer
    B BRAUN MELSUNGEN AG
    Product Code
    MEB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    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 MEDICAL INTERNAL REPORT NUMBER (B)(4). RECEIVED ONE EASYPUMP II LT 100-50-S-EU/SA WITHOUT ORIGINAL PACKAGING. AS RECEIVED CONDITION, THE SAMPLE WAS CLAMPED AND THE PATIENT CONNECTOR WAS NOT ATTACHED WITH WING CAP. THE BATCH NUMBER ON THE BIG BOTTOM CAP WAS 23C18GED81. PRELIMINARY INVESTIGATION OBSERVED NO CRACK AND NO CRYSTALLIZATION WAS OBSERVED AROUND THE FILTER. WHEN UNCLAMPED, LEAKAGE WAS OBSERVED FROM THE FILTER AIR VENT AFTER UNCLAMPING THE SAMPLE. RED DYE WATER WAS ALLOWED TO PASS THROUGH THE FILTER FOR BETTER ILLUSTRATION OF LEAKAGE AT FILTER. SOLUTION WAS LEAKING FROM THE AIR VENT HOLE. FILTER IS A PURCHASED COMPONENT FROM SUPPLIER. AFFECTED FILTER BATCH: 229260. SUMMARY OF ROOT CAUSE ANALYSIS: FILTER AIR VENT LEAKAGE WAS OBSERVED FROM THE RETURNED COMPLAINT SAMPLE. HENCE, THIS COMPLAINT IS CONSIDERED AS CONFIRMED. CAUSE : FAILURE FROM SUPPLIER. CORRECTIONS/CONTAINMENT PLANS WITH EFFECTIVE DATE: NOT APPLICABLE. CORRECTIVE ACTIONS: 1. Z2 NOTIFICATION WAS ISSUED TO THE SUPPLIER (200350497 FOR AFFECTED FILTER BATCH 229260). 2. AN APPROVED PROJECT IS IN PLACE TO FURTHER ADDRESS ISSUES WITH LEAKAGE. JUSTIFICATION: 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

    AS REPORTED BY THE USER FACILITY INFORMATION BY BBM SALES ORGANIZATION IN SWITZERLAND: "CHEMO LEAKAGE". ACCORDING TO THE COMPLAINANT THE PUMP TUBING LEAKED DURING THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    543579 EASYPUMP 2 ELASTOMERIC PUMP MEB B BRAUN MELSUNGEN AG 4540016-07 23C18GED81

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown