BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTINU-FLO SOLUTION INFUSIONSET COLLEAGUE AND FLOGARD

    MDR report key: 1932609 · Received December 19, 2010

    Report

    Report Number
    6000001-2010-06012
    Event Type
    Malfunction
    Date Received
    December 19, 2010
    Date of Event
    June 23, 2010
    Report Date
    June 24, 2010
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE IS NOT AVAILABLE FOR EVALUATION; THEREFORE, THE CONDITION CANNOT BE CONFIRMED OR DUPLICATED AND THE ASSIGNABLE ROOT CAUSE COULD NOT BE DETERMINED. IF ADDITIONAL INFORMATION OR SAMPLES BECOME AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED. THIS DEVICE IS MANUFACTURED FOR DISTRIBUTION OUTSIDE OF THE UNITED STATES (US); THEREFORE, IT DOES NOT CONTAIN A US 510K NUMBER. HOWEVER, THIS MDR IS BEING SUBMITTED BECAUSE IT IS THE SAME AS OR SIMILAR TO A PRODUCT DISTRIBUTED WITHIN THE US.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BAXTER (B)(4) OF A CONTINU-FLO SOLUTION INFUSION SET WHERE IT'S NOT POSSIBLE TO BACK-PRIME. IN THE ONCOLOGY CENTER, THE CUSTOMER USE ADD-A-LINE AND ON ADDING THIS TO THE CLEAR LINK INJECTION PORT THE CUSTOMER WAS UNABLE TO BACK-PRIME DESPITE UN-DOING AND RE-TRYING SEVERAL TIMES. IT IS UNKNOWN WHEN THIS EVENT OCCURRED. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS REPORT. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTINU-FLO SOLUTION INFUSIONSET COLLEAGUE AND FLOGARD SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1 ADD-A-LINE SET