BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 2981116 · Received February 27, 2013

    Report

    Report Number
    1416980-2013-04792
    Event Type
    Malfunction
    Date Received
    February 27, 2013
    Report Date
    February 11, 2013
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FPA
    PMA / PMN Number
    K961225
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE EXACT DATE OF THIS EVENT IS UNKNOWN; HOWEVER, THE EVENT OCCURRED DURING (B)(6) 2013.THE SAMPLE WAS NOT AVAILABLE FOR EVALUATION. THE CUSTOMER'S REPORTED PROBLEM WAS NOT CONFIRMED; THE ROOT CAUSE WAS NOT IDENTIFIED. A BATCH REVIEW CANNOT BE PERFORMED SINCE THERE WAS NO LOT NUMBER PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN UNKNOWN NUMBER OF CLEARLINK CONTINU-FLO SOLUTION SET WITH DUO-VENT WERE DIFFICULT TO PRIME. IT IS UNKNOWN IF THERE WAS PATIENT INVOLVEMENT; THERE WAS NO REPORT OF PATIENT INJURY, MEDICAL INTERVENTION, OR ADVERSE EVENT IN ASSOCIATION WITH THIS EVENT. ADDITIONAL INFORMATION WAS REQUESTED AND IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    84231 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1