BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VALVE SET, EM2400

    MDR report key: 14043834 · Received April 7, 2022

    Report

    Report Number
    1416980-2022-01641
    Event Type
    Malfunction
    Date Received
    April 7, 2022
    Date of Event
    March 10, 2022
    Report Date
    May 20, 2022
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    LHI
    UDI-DI
    00085412477183
    PMA / PMN Number
    K002705
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INITIAL REPORTER PHONE NO. (B)(6). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    H10: THE DEVICE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    B5: UPON FURTHER INVESTIGATION, IT WAS DETERMINED THAT THE AFFECTED PRODUCTS WERE TWO (2) EM2400 VALVE SETS, PREVIOUSLY SUBMITTED AS ¿AN UNSPECIFIED QUANTITY OF EMPTY NUTRITION BAGS¿. THE NUTRITION BAS APPEARED CLOUDY AS THE VALVE SETS WERE LEAKING UNINTENDED INGREDIENTS THROUGH THE FLUID PATH AND INTO THE BAGS. D1: THE CORRECT BRAND NAME IS ¿VALVE SET, EM2400¿, PREVIOUSLY SUBMITTED ¿NI¿. D4: THE CORRECT CATALOGUE # IS ¿H938724¿, PREVIOUSLY SUBMITTED AS ¿ASKU¿. D4: THE CORRECT LOT # IS ¿60333005¿, PREVIOUSLY SUBMITTED AS ¿ASKU¿. D4: THE UDI # IS ¿(01)00085412477183¿, PREVIOUSLY SUBMITTED AS ¿NI¿. G4: 510K #: THE CORRECT # IS ¿K002705¿, PREVIOUSLY SUBMITTED AS ¿NI¿. H4: THE LOT WAS MANUFACTURED FROM NOVEMBER 17, 2021 ¿ NOVEMBER 18, 2021. H10: SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF EMPTY NUTRITION BAGS WERE DISCOLORED. THE DISCOLORATION WAS FURTHER DESCRIBED AS, ¿APPEARING CLOUDY¿. THESE ISSUES WERE 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
    1164690 VALVE SET, EM2400 SET, I.V. FLUID TRANSFER LHI BAXTER HEALTHCARE CORPORATION NA 60333005 00085412477183

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown