BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTINU-FLO SOLN. SET, 3 LUERACTIVATED VALVES

    MDR report key: 2013332 · Received March 10, 2011

    Report

    Report Number
    6000001-2011-01761
    Event Type
    Malfunction
    Date Received
    March 10, 2011
    Date of Event
    February 1, 2011
    Report Date
    February 22, 2011
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FPA
    PMA / PMN Number
    K961225
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS RECEIVED FOR EVALUATION ON 03/08/2011. ONE ACTUAL SAMPLE WAS RECEIVED FOR THE REPORTED CONDITION OF A CUT NEAR A CHECK VALVE. A VISUAL INSPECTION DETERMINED ALL COMPONENTS WERE PRESENT, IN THE RIGHT POSITION AND COMPLETE. THE SAMPLE WAS THEN SUBMITTED FOR AN UNDERWATER PRESSURE TEST AND THE REPORTED CONDITION WAS CONFIRMED. ALTHOUGH THE REPORTED CONDITION WAS CONFIRMED, THE ROOT CAUSE OF THIS CONDITION COULD 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 BAXTER A CONTINU-FLO SOLUTION SET IN WHICH A "CUT NEAR A CHECK VALVE" WAS DETECTED. THE REPORTER STATED THAT IT APPEARED THE CUT COULD HAVE POSSIBLY OCCURRED DURING PACKAGING. THE CONDITION WAS IDENTIFIED 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 R10K27017

    Patients

    Seq Age Sex Outcome Treatment
    1