BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 3170624 · Received June 14, 2013

    Report

    Report Number
    1416980-2013-15402
    Event Type
    Malfunction
    Date Received
    June 14, 2013
    Report Date
    May 21, 2013
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FPA
    PMA / PMN Number
    K961225
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AS THE SAMPLE WAS NOT AVAILABLE, AN EVALUATION COULD NOT BE PERFORMED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A CLEARLINK CONTINU-FLO SOLUTION SET BECAME DISCONNECTED FROM A NON-BAXTER PRODUCT DURING PRIMING. THERE WAS NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION WAS REQUESTED BUT IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271386 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1