BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANTI-REFLUX "Y" SET

    MDR report key: 1024130 · Received April 5, 2008

    Report

    Report Number
    6000001-2007-04164
    Event Type
    Malfunction
    Date Received
    April 5, 2008
    Date of Event
    January 26, 2007
    Report Date
    January 30, 2007
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FPA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    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 MAR 01 2007. THE REPORTED DEVICE IS NOT AVAILABLE AND WILL NOT BE RETURNED FOR EVALUATION. THE MANUFACTURING FACILITY HAS BEEN MADE AWARE OF THIS REPORT THROUGH BAXTER'S COMPLAINT MANAGEMENT TRACKING SYSTEM. THE MANUFACTURING FACILITY WILL CONTINUE TO MONITOR SIMILAR REPORTS FOR POSSIBLE TRENDS.

    Description of Event or Problem · 1

    REPORT STATES: THE CUSTOMER REPORTED, THAT THE PATIENT HAD 2 PERIPHERAL IVS, BOTH WITH Y CONNECTORS. THE FIRST IV HAD TPN SOLUTION RUNNING AND THE SECOND IV HAD AN ANTIBIOTIC SOLUTION (UNKNOWN). THE CUSTOMER REPORTED, THAT THE MORNING OF THE EVENT, THE TPN LINE WAS FOUND TO BE LEAKING BETWEEN THE CONNECTION OF THE "Y" (SHORT SIDE) AND THE IV TUBING. THE CUSTOMER REPORTED, THAT THE "Y" WAS RELPLACED WITH THE ADDITION OF AN INTERLINK CAP AND A "BLUE"CONNECTOR. AFTER 15 MINUTES, THE LINE WAS FOUND TO BE LEAKING FROM THE CONNECTION BETWEEN THE INTERLINK CAP AND "Y" CONNECTION. THE CAP WAS TIGHTENED BY ONE OF THE NURSES AND THE "Y" BIFURCATION CRACKED. THE NURSE LEFT THE PUMP RUNNING AND THE LINE DRIPPED BLOOD AND TPN SOLUTION FROM THE CRACK ON THE BED. THE PATIENT IS REPORTED TO HAVE LOST A TOTAL OF APPROXIMATELY 100ML OF BLOOD AND TPN DURING THE EVENT. A ALTERNATE PRODUCT WAS USED AND ALL WENT WELL. THE PATIENT REPORTED THAT LATER THE SAME DAY ON THE SECOND IV, THE "Y" CONNECTOR LEAKED AGAIN. THE SAMPLE IS NOT AVAILABLE. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANTI-REFLUX "Y" SET ANESTHESIA EXTENSION SET FPA BAXTER HEALTHCARE CORPORATION NA UR339051

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR Required Intervention