BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINICAP EXTEND LIFE PD TRANSFER SET - JAPAN

    MDR report key: 1230089 · Received November 17, 2008

    Report

    Report Number
    1423500-2007-88844
    Event Type
    Injury
    Date Received
    November 17, 2008
    Date of Event
    May 19, 2007
    Report Date
    June 8, 2007
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    PMA / PMN Number
    K883239
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    BAXTER JAPAN REPORTED THAT THE CATHETER ADAPTER SEPARATED FROM THE TRANSFER SET DURING PATIENT USE (2007). THE PATIENT SUBSEQUENTLY CONNECTED THE SET TO THE ADAPTOR AND CONTINUED THERAPY. AT ABOUT 11 DAYS LATER, THE HOME PATIENT HAD DEVELOPED CLOUDY EFFLUENT AND ELEVATED WHITE BLOOD CELL (WBC) COUNT. HOWEVER, THE PATIENT DID NOT EXHIBIT ANY ADDITIOINAL SYMPTOMS OF PERITONITIS. THA PATIENT WAS HOSPITALIZED IN THE NEXT DAY. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MINICAP EXTEND LIFE PD TRANSFER SET - JAPAN 78KDJ KDJ BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization DIANEAL PD-4 1.5% SOLUTION (5 L)| DIANEAL PD-4 1.5% SOLUTION (2 L)