BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 3073051 · Received April 23, 2013

    Report

    Report Number
    1416980-2013-10086
    Event Type
    Malfunction
    Date Received
    April 23, 2013
    Report Date
    January 22, 2013
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FPA
    PMA / PMN Number
    K961225
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS NOT RETURNED FOR EVALUATION; THEREFORE, A DEVICE ANALYSIS COULD NOT BE PERFORMED. IF ADDITIONAL RELEVATION INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE IS NOT AVAILABLE FOR EVALUATION. A FOLLOW-UP REPORT WILL BE FILED IF ANY ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A CLEARLINK CONTINU-FLO SOLUTION SET WAS OBSERVED TO HAVE MICRO-BUBBLES IN THE TUBING. THE PROCESS STEP AND PATIENT INVOLVEMENT ARE BOTH UNKNOWN. ADDITIONAL INFORMATION WAS REQUESTED AND IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173840 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1