BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYPUMP

    MDR report key: 11847555 · Received May 19, 2021

    Report

    Report Number
    9610825-2021-00180
    Event Type
    Malfunction
    Date Received
    May 19, 2021
    Report Date
    May 19, 2021
    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

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MELSUNGEN AG INTERNAL REPORT # (B)(4): 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 20G02GE221, 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 RATE PROBLEM: AZACTAM MOLECULE. ON 12 HOURS, WITH 120 ML, ALL THE TREATMENT FLOW OVER 10 HOURS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    748229 EASYPUMP PUMP, INFUSION, ELASTOMERIC MEB B. BRAUN MELSUNGEN AG 20G02GE221

    Patients

    Seq Age Sex Outcome Treatment
    1