BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLEARLINK BURETROL SOLUTION SETS

    MDR report key: 17119961 · Received June 13, 2023

    Report

    Report Number
    1416980-2023-02889
    Event Type
    Malfunction
    Date Received
    June 13, 2023
    Report Date
    July 19, 2023
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FPA
    PMA / PMN Number
    K123874
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B5: CHANGE TO AN UNSPECIFIED QUANITY OF CLEARLINK BURETROL SOLUTION SETS (PREVIOUSLY REPORTED AS ONE SET). D1: REMOVE NI AND ADD BRAND NAME. D4: CATALOGUE #: REMOVE NI AND ADD 2C8862. G1: REMOVE NI¿S AND ADD DEVICE MANUFACTUER NAME/LOCATION AND ADDRESS INFORMATION. G4: PMA/510K: REMOVE NI AND ADD K123874. H10: THE ACTUAL DEVICE WAS NOT AVAILABLE; HOWEVER, PHOTOGRAPHS OF THE SAMPLE WERE PROVIDED FOR EVALUATION. VISUAL INSPECTION DID NOT IDENTIFY ANY ABNORMALITIES THAT COULD HAVE CONTRIBUTED TO THE REPORTED CONDITION. THE REPORTED CONDITION COULD NOT BE VERIFIED BY INSPECTION OF THE PHOTOGRAPHS. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    E1: INITIAL REPORTER ADDRESS: (B)(6). THE DEVICE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN; 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 AN UNSPECIFIED ACCESS SET HAD AIR IN THE LINE; FURTHER DESCRIBED AS BUBBLES BELOW THE CHAMBER. THIS WAS DISCOVERED DURING USE. 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
    1999281 CLEARLINK BURETROL SOLUTION SETS SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE CORPORATION NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown