BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLUTION SET WITH CAPLESS LUER ACTIVATED VALVE

    MDR report key: 1160195 · Received September 16, 2008

    Report

    Report Number
    6000001-2007-00145
    Event Type
    Malfunction
    Date Received
    September 16, 2008
    Date of Event
    November 23, 2006
    Report Date
    December 7, 2006
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    MEB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING RESUBMITTED IN ACCORDANCE WITH INSTRUCTIONS FROM FDA TO ADDRESS A MANUFACTURER REPORT SEQUENCE NUMBER ISSUE THAT OCCURRED WHEN THIS MDR OR SUPPLEMENT WAS ORIGINALLY SUBMITTED TO THE FDA ON JAN 03 2007. UNUSED SAMPLES HAVE BEEN REQUESTD FOR EVALUATION. IF SAMPLES ARE RECEIVED AND AN EVALUATION PERFORMED, A FOLLOW-UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED AN INCIDENT WERE THE TUBING LEAKED AT THE BOTTOM OF THE BURETTE CHAMBER DURING PATIENTS CHEMO TREATMENT. PATIENT DID NOT RECEIVE FULL DOSE OF CHEMO DUE TO LEAK. FAMILY NOTICED A SMALL CHEMO LEAK 20 MINUTES AFTER PATIENTS THERAPY STARTED. NURSE STOPPED THERAPY AND SMALL CRACK WAS NOTICED AT THE BOTTOM OF THE BURRETTE CHAMBER. CHEMO AND TUBING WERE REMOVED FROM PATIENT. CHEMO RESPIKED ON NEW BURETROL SET. CHEMO THAT WAS LOST WAS PLACED IN NEXT BAG. NURSE WAS AGAIN CALLED TO PATIENTS ROOM, FAMILY AGAIN NOTICED LEAKING THIS TIME FROM THE TOP OF THE BURETTE CHAMBER. NO PATIENT INJURY HAS BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOLUTION SET WITH CAPLESS LUER ACTIVATED VALVE SOLUTION ADMINISTRATION SET MEB BAXTER HEALTHCARE CORPORATION N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1