BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EM 2400, MAIN MODULE

    MDR report key: 14159935 · Received April 20, 2022

    Report

    Report Number
    1416980-2022-01923
    Event Type
    Malfunction
    Date Received
    April 20, 2022
    Date of Event
    March 25, 2022
    Report Date
    May 19, 2022
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    NEP
    UDI-DI
    00085412482637
    PMA / PMN Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HAS BEEN RECEIVED AND THE EVALUATION IS IN PROGRESS. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    CORRECTION MADE TO G1: BAXTER HEALTHCARE - ENGLEWOOD 14445 GRASSLANDS DRENGLEWOOD, CO. 80112 UNITED STATES (PREVIOUSLY SUBMITTED AS PLEXUS CORPORATION 2500 MILLBROOK DRIVE BUFFALO GROVE IL. 60089 UNITED STATES). H10: THE DEVICE WAS RECEIVED FOR EVALUATION. A VISUAL INSPECTION WAS PERFORMED AND FOUND RUST SPOTS ON THE PUMP DOOR MAGNETS, TORN AWAY OCCLUSION DETECTOR MEMBRANE, TOP PLATE PAINT SCRATCHED AND CHIPPED, MAIN MODULE COVER CORRODED, DAMAGED ROTOR ASSEMBLY KEYHOLE, WORN RUBBER FEET AND TWO RUBBER RECESSED BUMPERS. FUNCTIONAL AND ELECTRICAL TESTING WAS PERFORMED AND COMPLETED SUCCESSFULLY. THE REPORTED CONDITION WAS VERIFIED. THE SMALL AREAS OF RUST AND STAINING DID NOT IMPACT FUNCTION OF THE DEVICE AND IS CONSIDERED COSMETIC IN NATURE. THE DIRECT CAUSE OF THE REPORTED ISSUE IS END USER INDUCED, THE UNIT WAS NOT KEPT CLEAN AND DRY AFTER INGREDIENT SPILLAGE. THE PUMP COVER WITH MAGNETS WILL ALL BE REPLACED DURING THE REFURBISHMENT PROCESS. A SERVICE HISTORY REVIEW WAS PERFORMED AND REVEALED THAT THE DEVICE HAS NO PREVIOUS SERVICE EVENTS; THEREFORE, SERVICING DID NOT CAUSE OR CONTRIBUTE TO THE REPORTED EVENT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE GREEN DOOR OF A EM 2400, MAIN MODULE WAS DAMAGED. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2750598 EM 2400, MAIN MODULE SYSTEM/DEVICE, PHARMACY COMPOUNDING NEP BAXTER HEALTHCARE CORPORATION NA NA 00085412482637

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown