BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYPUMP

    MDR report key: 10677809 · Received October 14, 2020

    Report

    Report Number
    9610825-2020-00247
    Event Type
    Malfunction
    Date Received
    October 14, 2020
    Report Date
    December 15, 2020
    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 EVENT TWO OF B. BRAUN MEDICAL INC. INTERNAL REPORT NUMBER (B)(4). SIX (6) SAMPLES WERE RECEIVED FOR .EVALUATION IN REGARDS TO THE REPORTED ISSUE OF BLACK PARTICULATE STUCK TO THE INNER MEMBRANE OF THE PUMP. PARTICULATE WAS FOUND IN ALL SIX (6) OF THE RETURNED SAMPLES. IN THREE (3) OF THE SAMPLES WITH PARTICULATE ONE (1) PIECE OF PARTICULATE SMALLER THAN 0.8MM2 WAS FOUND, AND THIS IS WITHIN THE PRODUCT SPECIFICATION. IN ONE (1) SAMPLE A PIECE OF PARTICULATE GREATER THAN 0.8MM2 WAS FOUND, AND IN TWO (2) OTHER SAMPLES MULTIPLE PIECES OF PARTICULATE WERE FOUND. THESE THREE (3) DEVICES WERE FOUND TO BE OUT OF SPECIFICATION. ALL OF THE PIECES OF PARTICULATE WERE REMOVED AND 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. ALL OF THE PARTICULATE MATTER IN THE RETURNED SAMPLES WAS FOUND ABOVE THE DEVICES' EIS FILTERS. THE EIS FILTER CAN FILTER PARTICLES WITH THE SIZE OF 1.2M. ALL OF THE PARTICULATE FOUND IN THE RETURNED SAMPLES 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 EVENT TWO OF B. BRAUN MEDICAL INC. INTERNAL REPORT NUMBER (B)(4). THE INVESTIGATION INTO THIS REPORTED EVENT IS ONGOING. ADDITIONAL ATTEMPTS TO RECEIVE THE DEVICE INVOLVED IN THE REPORTED INCIDENT 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: EVENT 2; BLACK PARTICULATE APPEARS TO BE STUCK TO THE INNER MEMBRANE OF THE PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1142936 EASYPUMP PUMP, INFUSION, ELASTOMERIC MEB B. BRAUN MELSUNGEN AG 4540040-02 19K19GE672 04046964448942

    Patients

    Seq Age Sex Outcome Treatment
    1