BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYPUMP

    MDR report key: 10398460 · Received August 12, 2020

    Report

    Report Number
    9610825-2020-00173
    Event Type
    Malfunction
    Date Received
    August 12, 2020
    Date of Event
    July 7, 2020
    Report Date
    August 12, 2020
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    MEB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN (B)(4) INTERNAL REPORT # (B)(4) AS NO SAMPLE AND NO PICTURE WAS PROVIDED FOR INVESTIGATION A MALFUNCTION COULD NOT BE DETECTED: THE COMPLAINT IS ONLY TAKEN TO KNOWLEDGE AND FILED FOR STATISTICAL PURPOSES. DEVICE HISTORY RECORD (DHR): REVIEWED THE DHR FOR BATCH 18G03GE271 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 THROUGH NOTIVISA(TRANSLATION OF USER FACILITY INFORMATION BY BBM SALES ORGANIZATION IN (B)(4)): DAMAGED/PRODUCT/OVER INFUSION NOTIVISA IS THE COMPUTERIZED SYSTEM FOR REPORTING COMPLAINTS TO ANVISA, THE NATIONAL HEALTH SURVEILLANCE AGENCY IN BRAZIL. THROUGH THIS SYSTEM, ALL CUSTOMER ARE ABLE TO PROCEED WITH ANY KIND OF COMPLAINT. NOTIVISA NUMBER: 2020.07.002303. AS REPORTED BY THE CUSTOMER:"FLUOROURACIL MEDICINE THAT WAS MADE IN THE ELASTOMERIC INFUSION PUMP COMPLETED BEFORE THE TIME."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    863147 EASYPUMP PUMP, INFUSION, ELASTOMERIC MEB B. BRAUN MELSUNGEN AG 18G03GE271

    Patients

    Seq Age Sex Outcome Treatment
    1