BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLEARLINK SOLUTION ADMINISTRATION SETS

    MDR report key: 14219741 · Received April 27, 2022

    Report

    Report Number
    1416980-2022-02065
    Event Type
    Malfunction
    Date Received
    April 27, 2022
    Report Date
    June 2, 2022
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FPA
    PMA / PMN Number
    2C8858
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL REPORTER CITY: (B)(6). DEVICE MANUFACTURER ADDRESS 1: (B)(4). SUSPECTED LOT #: R21L11094 SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    CORRECTION TO B5, D1 (BRAND NAME), D4 CATALOGUE # AND G4 510K#. B5: THE AFFECTED PRODUCT WAS ¿PACLITAXEL SET¿, PREVIOUSLY SUBMITTED AS ¿CLEARLINK SYSTEM; NON-DEHP CONTINU-FLO SOLUTION SETS¿. D1: THE CORRECT BRAND NAME IS ¿CLEARLINK SOLUTION ADMINISTRATION SETS¿, PREVIOUSLY SUBMITTED AS ¿CLEARLINK CONTINU-FLO SOLUTION SET¿ D4: THE CORRECT CATALOGUE # IS ¿2C8858¿, PREVIOUSLY SUBMITTED AS ¿2R8537¿. G4: THE CORRECT 510K # IS ¿K160007¿, PREVIOUSLY SUBMITTED AS ¿K180739¿. H10: THE ACTUAL DEVICES WERE NOT AVAILABLE; HOWEVER, A PHOTOGRAPH OF THE SAMPLE WAS PROVIDED FOR EVALUATION. A VISUAL INSPECTION WAS PERFORMED TO THE PHOTOGRAPH USING THE NAKED EYE WHICH DID NOT IDENTIFY ANY ABNORMALITIES THAT COULD HAVE CONTRIBUTED TO THE REPORTED CONDITION. THE REPORTED CONDITION WAS NOT CLEARLY OBSERVED ON THE PROVIDED PHOTOGRAPH AND DUE TO THE NATURE OF THE RETURNED SAMPLE NO ADDITIONAL TESTING COULD BE PERFORMED. THEREFORE, THE REPORTED CONDITION WAS NOT VERIFIED. A BATCH REVIEW COULD NOT BE CONDUCTED SINCE THE SUPECTED LOT NUMBER IS INVALID. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THREE (3) UNITS OF CLEARLINK SYSTEM; NON-DEHP CONTINU-FLO SOLUTION HAD ¿LIQUID COMING OUT OF THE AIR CHAMBER¿ (DRIP CHAMBER). THIS WAS OBSERVED DURING PRIMING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1841741 CLEARLINK SOLUTION ADMINISTRATION SETS SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE CORPORATION NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown