BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYPUMP® II

    MDR report key: 12870772 · Received November 24, 2021

    Report

    Report Number
    9610825-2021-00483
    Event Type
    Malfunction
    Date Received
    November 24, 2021
    Date of Event
    October 15, 2021
    Report Date
    June 7, 2022
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    MEB
    UDI-DI
    04046964448515
    PMA / PMN Number
    K081905
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INC. INTERNAL REPORT NUMBER (B)(4). FAILURE ANALYSIS AND INVESTIGATION RESULTS DID NOT CONFIRM THE REPORTED ISSUE. UPON RECEIPT THE ACTUAL PUMP INVOLVED WAS VISUALLY AND FUNCTIONALLY INSPECTED. THREE (3) VOLUMETRICS OF 250ML/HR AND 25ML WERE PERFORMED AND TESTED IN SPEC. THE PUMP OPERATED AS INTENDED AND THE REPORTED FAILURE COULD NOT BE REPRODUCED. BASED ON THE RESULTS OF THE INVESTIGATION, NO CONCLUSIONS CAN BE MADE REGARDING THE CAUSE OF THE REPORTED EVENT. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MELSUNGEN AG INTERNAL REPORT (B)(4): EVENT 1: AS NO SAMPLE AND NO MEANINGFUL PICTURE WAS PROVIDED, PROPER INVESTIGATION ON MALFUNCTION COULD NOT BE PERFORMED. HENCE, THE COMPLAINT IS CONSIDERED AS NOT CONFIRMED. DEVICE HISTORY RECORD (DHR: REVIEWED THE DHR FOR BATCH 21B03GE231, THERE IS NO ABNORMALITY AND NO SUCH DEFECT DETECTED AT IN PROCESS AND AT FINAL CONTROL INSPECTION. 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 FRANCE: EVENT 1: "PUMP-FLOW RATE-FAST." "2 DIFFUSERS FILLED TO 48ML TO PASS OVER 24 HOURS PASSED IN HALF THE TIME, I.E. 12 HOURS. THE EVENT OCCURRED IN THE SAME PATIENT TWICE. THERE WERE NO CONSEQUENCES FOR THE PATIENT. NO SAMPLE AVAILABLE OCCURENCE DATE : (B)(6) 2021."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1766659 EASYPUMP® II ELASTOMERIC INFUSION PUMP MEB B. BRAUN MELSUNGEN AG 4540010-02 21B03GE231 04046964448515

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown