BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTINU-FLO SOLN. SET, 3 LUERACTIVATED VALVES

    MDR report key: 2011587 · Received March 9, 2011

    Report

    Report Number
    6000001-2011-01715
    Event Type
    Malfunction
    Date Received
    March 9, 2011
    Date of Event
    February 1, 2011
    Report Date
    February 14, 2011
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FPA
    PMA / PMN Number
    K961225
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    NURSE

    Narratives

    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.

    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.

    Description of Event or Problem · 1

    THE CUSTOMER STATED TO PRODUCT SURVEILLANCE THAT THERE WAS A CONTINU-FLO SET EXPERIENCING A NO FLOW EVENT. WHEN AN UNKNOWN SECONDARY SET WAS CONNECTED TO THE CONTINU-FLO, THERE WAS NO DRUG GOING INTO THE Y-SITE OF THE CONTINU-FLO SET. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED. THE CUSTOMER STATED THAT SHE WAS CAPABLE OF GETTING THE MEDICATION THROUGH THE SET AFTERWARDS; THEREFORE, THE CUSTOMER DISPOSED OF IT AFTER USE. 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 UNKNOWN DRUG, SECONDARY SET