BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLEARLINK SOLUTION ADMINISTRATION SETS

    MDR report key: 8668581 · Received June 4, 2019

    Report

    Report Number
    1416980-2019-03066
    Event Type
    Malfunction
    Date Received
    June 4, 2019
    Date of Event
    May 10, 2019
    Report Date
    July 5, 2019
    Manufacturer
    BAXTER HEALTHCARE - CARTAGO
    Product Code
    FPA
    PMA / PMN Number
    K160007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION : THE ACTUAL DEVICE WAS NOT AVAILABLE; HOWEVER, A PHOTOGRAPH OF THE SAMPLE WAS PROVIDED FOR EVALUATION. VISUAL INSPECTION WAS PERFORMED ON THE PHOTOGRAPH WITH NAKED EYE AND IT REVEALED THAT THE DAC SLEEVE APPEARED DETACHED FROM THE ADMINISTRATION PORT. THE REPORTED CONDITION WAS VERIFIED. THE CAUSE OF THE CONDITION COULD NOT BE DETERMINED.  SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED A PACLITAXEL SET WOULD NOT PRIME. THE PACLITAXEL SET WAS ATTACHED TO A VIAFLO BAG WHEN THE INCIDENT OCCURRED. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    461216 CLEARLINK SOLUTION ADMINISTRATION SETS SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - CARTAGO NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1