BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NI

    MDR report key: 14399645 · Received May 13, 2022

    Report

    Report Number
    1416980-2022-02417
    Event Type
    Malfunction
    Date Received
    May 13, 2022
    Date of Event
    April 16, 2022
    Report Date
    June 14, 2022
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    LHI
    PMA / PMN Number
    K002705
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    LOT NUMBER: THE REPORTED LOT NUMBER 60448034 IS NOT ASSOCIATED WITH ANY BAXTER PRODUCT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    CORRECTION TO B5, D4: CATALOGUE #, G4: 510K # AND G1: DEVICE MANUFACTURER FACILITY. B5: THE AFFECTED PRODUCT WAS "EM2400 VALVE SET", PREVIOUSLY SUBMITTED AS "UNSPECIFIED BAXTER ACCESS SETS" D4: THE CATALOGUE # IS "H938724", PREVIOUSLY SUBMITTED AS "ASKU". G4: THE 510K # IS K002705, PREVIOUSLY SUBMITTED AS "NI". G1: MANUFACTURING FACILITY-THIS DEVICE WAS MANUFACTURED AT ONE OF THE TWO FOLLOWING MANUFACTURING SITES: AVAILMED C. INDUSTRIAL LT. 001 MZ. 105 NO 20905 INT A, COL CD IND. TIJUANA, BAJA CALIFORNIA 22444, MEXICO OR BAXTER HEALTHCARE ¿ ENGLEWOOD 14445 GRASSLANDS DR ENGLEWOOD, CO. 80112 UNITED STATES. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PORTS OF TWO (2) UNSPECIFIED BAXTER ACCESS SETS (ALSO REPORTED AS A VALVE SET) LEAKED. THIS ISSUES WAS IDENTIFIED DURING SETUP AND PREPARATION 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
    909109 NI SET, I.V. FLUID TRANSFER LHI BAXTER HEALTHCARE CORPORATION NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown