BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTINU-FLO SOLN. SET, 3 LUERACTIVATED VALVES

    MDR report key: 2062778 · Received April 19, 2011

    Report

    Report Number
    6000001-2011-02963
    Event Type
    Malfunction
    Date Received
    April 19, 2011
    Date of Event
    April 1, 2011
    Report Date
    April 4, 2011
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FPA
    PMA / PMN Number
    K961225
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS RECEIVED FOR EVALUATION ON 04/27/2011. ONE CONTINU-FLO SOLUTION SET (2C8537) AND AN UNKNOWN EXTENSION SET WERE RECEIVED FOR EVALUATION. THE MALE LUER OF THE CONTINU-FLO SET WAS MATED TO BOTH THE FEMALE LUER AND Y-SITE OF THE UNKNOWN SET PER LABEL COPY WITH NO BACK OFF OR DISCONNECTION NOTED. SINCE THE MALE LUER OF THE CONTINU-FLO SET WAS SUCCESSFULLY MATED TO BOTH THE FEMALE LUER AND Y-SITE OF THE RETURNED UNKNOWN EXTENSION SET, THE COMPLAINT WILL NOT BE CONFIRMED AND THE ROOT CAUSE WAS NOT IDENTIFIED. A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE IS REPORTED TO BE AVAILABLE FOR EVALUATION. IF THE SAMPLE IS RECEIVED OR ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO A BAXTER SALES REPRESENTATIVE OF A CONTINU-FLO SOLUTION SET THAT "KEPT DISCONNECTING." IT IS UNKNOWN WHAT THE USER WAS ATTEMPTING TO CONNECT THIS SET TO. THE CONDITION OCCURRED DURING SET-UP BEFORE PATIENT USE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTINU-FLO SOLN. SET, 3 LUERACTIVATED VALVES SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE R11B12016

    Patients

    Seq Age Sex Outcome Treatment
    1