BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYPUMP II

    MDR report key: 17279248 · Received July 7, 2023

    Report

    Report Number
    9610825-2023-00314
    Event Type
    Malfunction
    Date Received
    July 7, 2023
    Date of Event
    June 8, 2023
    Report Date
    September 19, 2023
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    MEB
    PMA / PMN Number
    K062700
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    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). WE RECEIVED ONE USED AND EMPTY EASYPUMP II LT 270-135-S-EU/SA WITHOUT PACKAGE. AFTER THE SAMPLE WAS DECONTAMINATED, RED DYE WATER WAS ALLOWED TO PASS THROUGH THE FILTER FOR BETTER ILLUSTRATION OF LEAKAGE FROM THE AIR VENT OF THE FILTER. FILTER AIR VENT LEAKAGE WAS OBSERVED FROM THE RETURNED COMPLAINT SAMPLE. HENCE, THIS COMPLAINT IS CONSIDERED AS CONFIRMED. TO AVOID RECURRENCE OF THIS FAULT, CORRECTIVE MEASURE ALREADY HAS BEEN INITIATED. 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 SOUTH AFRICA: "CHEMO LEAKAGE." ACCORDING TO THE CUSOMER: "EASYPUMP WAS FILLED AND CONNECTED TO PATIENT AT ONCOLOGY UNIT. RAN AS EXPECTED AND INFUSED AT CORRECT RATE FOR DAY 1. STARTED LEAKING ON DAY 2 OF TREATMENT. PATIENT DISCONNECTED PUMP AND RETURNED FAULTY PUMP TO UNIT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    497290 EASYPUMP II ELASTOMERIC INFUSION PUMP MEB B. BRAUN MELSUNGEN AG 23A14GEE31

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown