BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTINU-FLO SOLN. SET, 3 LUERACTIVATED VALVES

    MDR report key: 2011603 · Received March 9, 2011

    Report

    Report Number
    6000001-2011-01716
    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

    A CUSTOMER REPORTED TO PRODUCT SURVEILLANCE OF A CONTINU-FLO SET EXPERIENCING A NO FLOW AND MAKING IT DIFFICULT TO PUSH MEDICATION THROUGH, WITH AN UNKNOWN SYRINGE IN THE Y-SITE NEAREST TO THE SPIKE DURING THE INFUSION ON A PATIENT. THE PATIENT WAS SUPPOSED TO RECEIVE AN ANTIBIOTIC, CIPIO, AND SHE DID NOT RECEIVE IT UNTIL 7 HOURS LATER. 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 81 YR CIPIO , UNKNOWN SYRINGE