BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINICAP EXTENDED LIFE PD TRANSFER SET (EASY-LOCK)

    MDR report key: 547302 · Received September 30, 2004

    Report

    Report Number
    1423500-2004-01017
    Event Type
    Injury
    Date Received
    September 30, 2004
    Date of Event
    August 30, 2004
    Report Date
    August 31, 2004
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    A PT NOTICED A LEAK IN THE TUBING OF THEIR MINICAP TRANSFER SET IN 2004 AFTER 6 1/2 MONTHS OF USE. THE LEAK WAS NOTED WHERE THE DARK BLUE PLASTIC CONNECTS TO THE CLEAR PLASTIC OF THE SET. THE PT WENT TO THE DIALYSIS UNIT THAT DAY FOR A TRANSFER SET CHANGE AND ADMINISTRATION OF PROPHYLACTIC ANTIBIOTICS 1 GM ANCEF IP. THE FOLLOWING DAY THE PT WENT BACK TO THE CLINIC WITH CLOUDY EFFLUENT AND A FEVER OVERNIGHT AND WAS DIAGNOSED WITH PERITONITIS. THE PT WAS ADMINISTERED 2000 MG VANCOMYCIN AND 110 MG TOBRAMYCIN IP X 1. THE PT WAS DISCHARGED HOME AND HAS FULLY RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MINICAP EXTENDED LIFE PD TRANSFER SET (EASY-LOCK) TRANSFER SET KDJ BAXTER HEALTHCARE CORPORATION NA NA03

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention