BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTINU-FLO SOLN. SET, 3 LUERACTIVATED VALVES

    MDR report key: 1992218 · Received February 15, 2011

    Report

    Report Number
    6000001-2011-01018
    Event Type
    Malfunction
    Date Received
    February 15, 2011
    Date of Event
    January 1, 2011
    Report Date
    January 28, 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). A 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.

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND 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 SAMPLE REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BAXTER OF A CONTINU-FLO SET IN WHICH IT WAS DIFFICULT FOR THE NURSE TO PUSH SALINE THROUGH THE FIRST Y-SITE, WHICH WAS BETWEEN THE CHECK VALVE AND THE CLAMP. FOLLOWING THE INCIDENT, THE NURSE WAS CAPABLE OF GETTING FLUID THROUGH THE Y-SITE. THE SYRINGE USED IN THIS INCIDENT WAS A CARDINAL 10 ML SYRINGE, AND A SIGMA PUMP WAS ALSO BEING UTILIZED. THIS WAS DISCOVERED DURING PATIENT-USE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INVOLVED. 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 R10K29096

    Patients

    Seq Age Sex Outcome Treatment
    1 SALINE, CARDINAL SYRINGE, SIGMA PUMP