BEUDAMED
    FDA Adverse Event Summary report: N

    CONTINU-FLO SOLN. SET, 3 LUERACTIVATED VALVES

    MDR report key: 1758613 · Received July 15, 2010

    Report

    Report Number
    6000001-2010-01520
    Date Received
    July 15, 2010
    Date of Event
    April 1, 2010
    Report Date
    April 15, 2010
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FPA
    PMA / PMN Number
    K003225
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE IS NOT AVAILABLE FOR EVALUATION, THEREFORE, THE CONDITION CANNOT BE CONFIRMED OR DUPLICATED AND THE ASSIGNABLE ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO THEIR BAXTER SALES REPRESENTATIVE (BSR) THAT ON (B)(6) 2010 THE CLEARLINK CONTINU-FLO SOLUTION SET LEAKED CHEMOTHERAPY DRUGS FROM THE UPPER Y-SITE. THE BSR REQUESTED LOT NUMBERS AND EVENT DATES FROM THE NURSE BUT TO DATE THERE HAS BEEN NO REPLY. THEY BELIEVE THIS MAY BE A TRAINING ISSUE AND REQUESTED A RE-TRAINING SESSION FROM THE BSR. THE CHEMOTHERAPY DRUG NEED TO BE RECALCULATED AND RE-ISSUED. THEIR CHEMOTHERAPY SPILL CLEAN UP STEPS HAD TO BE COMPLETED. A BAXTER PUMP WAS USED BUT THE PRODUCT INFORMATION IS UNKNOWN. THE LUER CONNECTIONS ARE SECURED IN SOME CASES, BUT IN OTHERS IT IS UNKNOWN. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION NECESSARY. NO OTHER INFORMATION WAS 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 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1