BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EM 2400, MAIN MODULE

    MDR report key: 14501803 · Received May 25, 2022

    Report

    Report Number
    1416980-2022-02646
    Event Type
    Malfunction
    Date Received
    May 25, 2022
    Date of Event
    April 29, 2022
    Report Date
    June 9, 2022
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    NEP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION MADE TO G1: BAXTER HEALTHCARE - ENGLEWOOD 14445 GRASSLANDS DR ENGLEWOOD CO. 80112 (PREVIOUSLY SUBMITTED AS PLEXUS CORPORATION 2500 MILLBROOK DRIVE BUFFALO GROVE, IL. 60089). H10: THE ACTUAL DEVICE WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION WAS PERFORMED AND THE TOP PLATE WAS OBSERVED SCRATCHED, THE MAIN MODULE COVER WAS STAINED AND HAD CORRODED PAINT, AND A SCRATCHED PUMP COVER AND WORN RUBBER FEET WAS OBSERVED. UNKNOWN FLUIDS WERE FOUND ON THE UNIT. FUNCTIONAL TESTS INCLUDING ELECTRICAL SAFETY AND FUNCTIONAL SYSTEM LEVEL TESTS WERE PERFORMED AND NO ISSUES WERE NOTED. DURING INSPECTION OF THE POWER SUPPLY, BURNT TRACES WERE IDENTIFIED ON THE POWER SUPPLY BOARD (PCB) AROUND COMPONENTS U4, U8 AND CAPACITOR C27 FROM FLUID INGRESS. THE REPORTED CONDITION WAS VERIFIED. THE CAUSE OF THE BURNING ODOR WAS DUE TO THE DAMAGED POWER SUPPLY BOARD, HOWEVER THE CAUSE OF THE DAMAGE COULD NOT BE DETERMINED. 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 EM 2400, MAIN MODULE AUTOMATED COMPOUNDING DEVICE (ACD) SMELLED LIKE BURNING. THIS ISSUE WAS IDENTIFIED DURING SETUP. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    391883 EM 2400, MAIN MODULE SYSTEM/DEVICE, PHARMACY COMPOUNDING NEP BAXTER HEALTHCARE CORPORATION NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown