BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BAXTER CLEARLINK SYSTEM

    MDR report key: 24237947 · Received February 2, 2026

    Report

    Report Number
    MW5183162
    Event Type
    Malfunction
    Date Received
    February 2, 2026
    Date of Event
    January 27, 2026
    Report Date
    January 28, 2026
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    A TUBING DEFECT WAS IDENTIFIED WITH BAXTER CLEARLINK PRODUCT: 2R8537, LOT #: (10)R25E30192, EXP; 2027-05-30. TUBING FAILURE, A DISCONNECTION AT THE LOWER Y-SITE, WAS IDENTIFIED WHILE PRIMING LINE WITH SALINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303620 BAXTER CLEARLINK SYSTEM SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE CORPORATION 2R8537 (10)R25E30192

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other