BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLEARLINK CONTINU-FLO W/2 PORTMANIFOLD - 10DPM NV

    MDR report key: 1760146 · Received July 16, 2010

    Report

    Report Number
    6000001-2010-01724
    Event Type
    Malfunction
    Date Received
    July 16, 2010
    Date of Event
    March 1, 2010
    Report Date
    March 2, 2010
    Manufacturer
    BAXTER HEALTHCARE - AIBONITO
    Product Code
    FPA
    PMA / PMN Number
    K932512
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RECEIVED FOR EVALUATION. SHOULD COMPANION SAMPLES BE RECEIVED FOR EVALUATION, A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF THE EVALUATION OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE. (B) (4)

    Description of Event or Problem · 1

    THE BAXTER SALES REPRESENTATIVE REPORTED, ON BEHALF OF THE CUSTOMER, A LOOSE CONNECTION WHICH CAUSED AN UNKNOWN AMOUNT OF BLOOD LOSS WHEN USING THE CLEARLINK CONTINU-FLO WITH 2 PORT MANIFOLD. THE BAXTER REPRESENTATIVE STATED THAT THE STAFF AT THE FACILITY BELIEVED TO HAVE ALL CONNECTIONS SECURE BUT NOTICED THE CONNECTIONS WERE STILL BECOMING LOOSE. THIS INCIDENT OCCURRED DURING PATIENT USE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS REPORT. NO ADDITIONAL INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLEARLINK CONTINU-FLO W/2 PORTMANIFOLD - 10DPM NV STOPCOCK, I.V. SET FPA BAXTER HEALTHCARE - AIBONITO UR10A11102

    Patients

    Seq Age Sex Outcome Treatment
    1