BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYPUMP

    MDR report key: 10183621 · Received June 23, 2020

    Report

    Report Number
    9610825-2020-00120
    Event Type
    Malfunction
    Date Received
    June 23, 2020
    Date of Event
    April 22, 2020
    Report Date
    June 23, 2020
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    MEB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SUMMARY AND ASSESSMENT: AS NO SAMPLE AND NO PICTURE WAS PROVIDED FOR INVESTIGATION A MALFUNCTION COULD NOT BE DETECTED. NOTE: DUE TO THE COVID-19 PANDEMIC, GLOBAL QM HAS INSTRUCTED SALES ORGANIZATION NOT TO SEND SAMPLES. DEVICE HISTORY RECORD (DHR): REVIEWED THE DHR FOR BATCH 19H01GE221, 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 · 1

    AS REPORTED BY THE USER FACILITY (TRANSLATION OF USER FACILITY INFORMATION BY BBM SALES ORGANIZATION IN (B)(6)): PUMP-FLOW RATE-FAST. FLOW IN LESS THAN 12 HOURS INSTEAD OF 24.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    650685 EASYPUMP PUMP, INFUSION, ELASTOMERIC MEB B. BRAUN MELSUNGEN AG 19H01GE221

    Patients

    Seq Age Sex Outcome Treatment
    1