BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLEARLINK/CONTINU-FLO

    MDR report key: 22114773 · Received May 30, 2025

    Report

    Report Number
    1416980-2025-03117
    Event Type
    Malfunction
    Date Received
    May 30, 2025
    Report Date
    July 23, 2025
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FPA
    UDI-DI
    00085412048987
    PMA / PMN Number
    K203609
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: H4, H6 (UPDATE CODES), H11. H4: THE SUSPECTED LOT WAS MANUFACTURED ON 01/20/2025. H11: A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS SUSPECTED 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.

    Additional Manufacturer Narrative · 0

    D4: LOT #: A SUSPECT LOT WAS IDENTIFIED - R25A18161. D4 (ADDITIONAL): EXPIRATION DATE OF SUSPECT LOT IS 01/19/2027 AND UDI # OF THE SUSPECTED LOT IS (B)(4). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BLUE CLAMP OF A CLEARLINK SYSTEM CONTINU-FLO SOLUTION SET DISINTEGRATED IN THE SLIDE CLAMP KEYHOLE OF A NOVUM IQ LARGE VOLUME PUMP. THE WAS OBSERVED DURING USE OF THE SET; HOWEVER, PATIENT INVOLVEMENT WAS NOT SPECIFIED. 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
    9783 CLEARLINK/CONTINU-FLO SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE CORPORATION 2C8546 ASKU 00085412048987

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown NOVUM IQ LVP.