BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLEARLINK CONTINU-FLO SOLUTION SET

    MDR report key: 11330703 · Received February 15, 2021

    Report

    Report Number
    1416980-2021-00655
    Event Type
    Malfunction
    Date Received
    February 15, 2021
    Report Date
    March 22, 2021
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FPA
    PMA / PMN Number
    K961225
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    H10: 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.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF CLEARLINK SYSTEM NON-DEHP CONTINU-FLO SOLUTION SETS WOULD NOT FLOW. IT WAS FURTHER REPORTED THAT THE SET "ISN¿T DRIPPING SO THE VEIN ISN¿T KVO" (KEEP VEIN OPEN). THIS ISSUE WAS IDENTIFIED DURING PATIENT INFUSION WITH AN UNSPECIFIED SOLUTION. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    223571 CLEARLINK CONTINU-FLO SOLUTION SET SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE CORPORATION NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 UNSPECIFIED SOLUTION