BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTINU-FLO SOLN. SET, 3 LUERACTIVATED VALVES

    MDR report key: 1992272 · Received February 15, 2011

    Report

    Report Number
    6000001-2011-01022
    Event Type
    Malfunction
    Date Received
    February 15, 2011
    Date of Event
    January 1, 2011
    Report Date
    January 27, 2011
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FPA
    PMA / PMN Number
    K961225
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    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. THE BATCH REVIEW CANNOT BE PERFORMED SINCE THERE WAS NO LOT NUMBER PROVIDED. IF ADDITIONAL INFORMATION OR SAMPLES BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). 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.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO A BAXTER SALES REPRESENTATIVE (BSR) OF A CONTINU-FLO SET IN WHICH THE TUBING BROKE DURING PATIENT USE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INVOLVED. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 2 OF 2 OF THE SAME REPORTED PROBLEM FROM THIS FACILITY.

    Description of Event or Problem · 1

    BAXTER'S SALES REP REPORTED THAT A SEPARATION OCCURRED AT THE JUNCTION BETWEEN THE TUBING AND THE Y-SITE NEAREST TO THE MALE LUER OF THE SET. THIS SEPARATION OCCURRED RELATIVE TO THE INFUSION. THIS OCCURRED DURING AN INFUSION; THERE WAS NO PATIENT INJURY / MEDICAL INTERVENTION INVOLVED. THERE WAS NO REPORT OF CONCOMMITANT PRODUCTS BEING UTILIZED. THE MEDICATION BEING INFUSED WAS UNKNOWN. THE SAMPLE IS NOT AVAILABLE FOR EVALUATION. IT IS UNKNOWN WHEN EXACTLY THIS CONDITION OCCURRED RELATIVE TO THE INFUSION. 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

    Patients

    Seq Age Sex Outcome Treatment
    1