BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYPUMP

    MDR report key: 10810498 · Received November 9, 2020

    Report

    Report Number
    9610825-2020-00289
    Event Type
    Malfunction
    Date Received
    November 9, 2020
    Report Date
    January 26, 2021
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    MEB
    UDI-DI
    04046964448942
    PMA / PMN Number
    K081905
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INC. INTERNAL REPORT NUMBER (B)(4). ONE (1) SAMPLE WAS RECEIVED FOR EVALUATION. PARTICULATE WAS FOUND IN THE SOLUTION. THE PARTICULATE WAS EXTRACTED AND MEASURED 0.297MM2, WHICH IS WITHIN THE PRODUCT SPECIFICATION. THE PARTICULATE WAS SENT FOR FTIR ANALYSIS TO DETERMINE THE COMPOSITION OF THE PARTICULATE. THE RESULTS OF THIS TESTING DID NOT MATCH ANY OF THE KNOWN SUBSTANCES WITHIN THE PRODUCTION PROCESS, AND COULD NOT BE IDENTIFIED AT THIS TIME. THE PARTICULATE MATTER IN THE RETURNED SAMPLE WAS FOUND ABOVE THE DEVICE'S EIS FILTER. THE EIS FILTER CAN FILTER PARTICLES WITH THE SIZE OF 1.2 M. THE PARTICULATE FOUND IN THE RETURNED SAMPLE WAS >1.2 M, AND WOULD BE FILTERED OUT BY THE EIS FILTER. BASED ON THE RESULTS OF THE INVESTIGATION, NO CONCLUSIONS CAN BE MADE REGARDING THE CAUSE OF THE REPORTED EVENT.

    Additional Manufacturer Narrative · 1

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INC. INTERNAL REPORT NUMBER 400491825. THE INVESTIGATION INTO THIS REPORTED EVENT IS ONGOING. ADDITIONAL ATTEMPTS TO RECEIVE THE DEVICE INVOLVED IN THE REPORTED EVENT ARE BEING MADE. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE RESULTS OF THE INVESTIGATION ARE AVAILABLE.

    Description of Event or Problem · 1

    AS REPORTED BY USER FACILITY: BLACK PARTICLE IN PUMP. ISSUE DISCOVERED IN THE PHARMACY DURING COMPOUNDING PROCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1274809 EASYPUMP PUMP, INFUSION, ELASTOMERIC MEB B. BRAUN MELSUNGEN AG 4540040-02 19N18GE672 04046964448942

    Patients

    Seq Age Sex Outcome Treatment
    1