BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLEARLINK/CONTINU-FLO/DUO-VENT

    MDR report key: 22565341 · Received July 22, 2025

    Report

    Report Number
    1416980-2025-03846
    Event Type
    Malfunction
    Date Received
    July 22, 2025
    Date of Event
    June 23, 2025
    Report Date
    July 22, 2025
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FPA
    PMA / PMN Number
    K203609
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    D4: LOT #: CUSTOMER PROVIDED A SUSPECT LOT# R25A13048 D4: EXPIRATION DATE (SUSPECT LOT): 01/13/2027 D4: UNIQUE IDENTIFIER (UDI) # (SUSPECT LOT): (B)(4)H4: THE LOT WAS MANUFACTURED ON 1/14/2025. D4: LOT #: CUSTOMER PROVIDED ANOTHER SUSPECT LOT# R25C29130 D4: EXPIRATION DATE (SUSPECT LOT): 03/30/2027 D4: UNIQUE IDENTIFIER (UDI) # (SUSPECT LOT): (B)(4) H4: THE LOT WAS MANUFACTURED ON 3/30/2025. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. THE DEVICE WAS NOT RECEIVED FOR EVALUATION; 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 THAT A CLEARLINK SYSTEM CONTINU-FLO SOLUTION SET LEAKED FROM THE Y-SITE. THE ISSUE WAS FURTHER DESCRIBED AS; IT APPEARED THAT THE SET LEAKED FROM THE PART IT IS GLUED/INSERTED. 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
    1755841 CLEARLINK/CONTINU-FLO/DUO-VENT SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE CORPORATION 2C8541 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown SALINE