BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLEARLINK/CONTINU-FLO/DUO-VENT

    MDR report key: 22755714 · Received August 8, 2025

    Report

    Report Number
    1416980-2025-04110
    Event Type
    Malfunction
    Date Received
    August 8, 2025
    Date of Event
    July 11, 2025
    Report Date
    September 3, 2025
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FPA
    UDI-DI
    00085412071107
    PMA / PMN Number
    K203609
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D4: LOT#, EXPIRATION DATE, UDI#/ H4: MANUFACTURING DATE: THE SUSPECTED LOTS AND LOT INFORMATION ARE: LOT R25C13178, EXPIRATION DATE 03/14/2027, UDI: (B)(4), MANUFACTURING DATE 3/14/2025. LOT R25D26048, EXPIRATION DATE 04/27/2027, UDI: (B)(4), MANUFACTURING DATE 4/28/2025. LOT R25E13109, EXPIRATION DATE 05/13/2027, UDI: (B)(4), MANUFACTURING DATE 5/14/2025. LOT R25D08062, EXPIRATION DATE 04/08/2027, UDI: (B)(4), MANUFACTURING DATE 4/9/2025. THE DEVICE WAS RECEIVED FOR EVALUATION. A VISUAL INSPECTION WAS PERFORMED, AND TUBING SEPARATED FROM THE SECOND Y-SITE CLEARLINK IN THE DOWNSTREAM PART WAS OBSERVED. THERE WAS LACK OF SOLVENT DURING EXAMINATION, AND THE SOLVENT DOES NOT APPLY UNIFORMED IN THE TUBING. THE REPORTED CONDITION WAS VERIFIED. THE CAUSE OF THE CONDITION COULD NOT BE DETERMINED. A BATCH REVIEW OF THE SUSPECTED LOTS 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 · 0

    H11: THE CAUSE OF THE ISSUE WAS AN IMPROPER MANUAL ASSEMBLY DUE TO A LACK OF SOLVENT AT THE TUBING DURING MANUFACTURING. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE TUBING OF A CLEARLINK SYSTEM CONTINU-FLO SOLUTION SET SEPARATED FROM THE Y-SITE HUB AND LEAKED. THE DEVICE CONTAINED LACTATED RINGER¿S FLUID. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203957 CLEARLINK/CONTINU-FLO/DUO-VENT SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE CORPORATION 2C8541 ASKU 00085412071107

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown LACTATED RINGER¿S FLUID.