BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLEARLINK/CONTINU-FLO/DUO-VENT

    MDR report key: 22196553 · Received June 12, 2025

    Report

    Report Number
    1416980-2025-03324
    Event Type
    Malfunction
    Date Received
    June 12, 2025
    Report Date
    July 14, 2025
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FPA
    UDI-DI
    00085412071107
    PMA / PMN Number
    K203609
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: D4, H4, H6 (UPDATE CODES), H11. D4 LOT #: THE CUSTOMER REPORTED THE LOT NUMBERS IN STOCK THAT MAY CONTAIN THE SUSPECT LOT IN THIS EVENT: R24L26079, R25C08130, R25C08123, R25B24093, R25C08154, R24K18147, R24L06048, R24319208 (NOT VALID), R24L18079, AND R24G08055. D4 AND H4 INFORMATION FOR THE FOLLOWING SUSPECT LOTS: R24L26079: THIS LOT WAS MANUFACTURED 12/27/2024. EXPIRATION DATE 12/27/2026. R25C08130: THIS LOT WAS MANUFACTURED 03/10/2025. EXPIRATION DATE 03/09/2027. R25C08123: THIS LOT WAS MANUFACTURED 03/09/2025. EXPIRATION DATE 03/09/2027. R25B24093: THIS LOT WAS MANUFACTURED 02/25/2025. EXPIRATION DATE 02/24/2027. R25C08154: THIS LOT WAS MANUFACTURED 3/10/2025. EXPIRATION DATE 03/09/2027. R24K18147: THIS LOT WAS MANUFACTURED 11/19/2024. EXPIRATION DATE 11/19/2026. R24L06048: THIS LOT WAS MANUFACTURED 12/07/2024. EXPIRATION DATE 12/06/2026. R24319208 (NOT VALID). R24L18079:THIS LOT WAS MANUFACTURED 12/19/2024. EXPIRATION DATE 12/18/2026. R24G08055: THIS LOT WAS MANUFACTURED 07/09/2024. EXPIRATION DATE 07/09/2026. H11: A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THESE SUSPECT LOTS (EXCEPT SUSPECT LOT R25B24093). SUSPECT LOT R25B24093 FAILED A PRESSURE TEST FOR ONE (1) UNIT; THE UNIT WAS REMOVED AND THE REMAINING UNITS FOR RELEASE MET SPECIFICATIONS. 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.

    Additional Manufacturer Narrative · 0

    SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A CLEARLINK CONTINU-FLO SOLUTION SET WAS LEAKING FROM AN UNSPECIFIED LOCATION. IT WAS NOT REPORTED IF A PATIENT WAS CONNECTED AT THE TIME OF THIS EVENT. 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
    1805670 CLEARLINK/CONTINU-FLO/DUO-VENT SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE CORPORATION 2C8541 NI 00085412071107

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown