BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EUROPEAN VALVE SET, EM2400

    MDR report key: 9447950 · Received December 10, 2019

    Report

    Report Number
    1416980-2019-06816
    Event Type
    Malfunction
    Date Received
    December 10, 2019
    Report Date
    January 14, 2020
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    LHI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS MANUFACTURED FROM APRIL 11, 20109 - APRIL 16, 2019. ONE (1) ACTUAL DEVICE WAS RECEIVED FOR EVALUATION. A VISUAL INSPECTION WAS PERFORMED, AND IT WAS NOTED THAT THERE WAS EXCESS SILICONE FLUID ON OUTSIDE SURFACE VALVE BODY. EXCESS SILICONE FLUID WAS ALSO OBSERVED ON THE OUTSIDE VALVE BODY PORTS AND INSIDE OF THE ALL THE VALVE CAPS. EXCESS SILICONE FLUID WAS ALSO OBSERVED ON THE INSIDE OF ALL VALVE BODY PORTS AND ON TOP OF ALL VALVE CORES. THE REPORTED CONDITION WAS VERIFIED. THE CAUSE OF THE REPORTED CONDITION COULD NOT BE DETERMINED. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN UNKNOWN OIL/ FLUID WAS OBSERVED IN THE PORTS OF AND UNSPECIFIED QUANTITY OF EM2400 VALVE SETS. THIS WAS IDENTIFIED PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1239888 EUROPEAN VALVE SET, EM2400 SET, I.V. FLUID TRANSFER LHI BAXTER HEALTHCARE CORPORATION NA 60180311

    Patients

    Seq Age Sex Outcome Treatment
    1