BEUDAMED
    FDA Adverse Event Other Summary report: N

    HOMECHOICE AUTOMATED PD SET W/CASSETTE 4-PRONG

    MDR report key: 376046 · Received February 7, 2002

    Report

    Report Number
    1423500-2002-00167
    Event Type
    Other
    Date Received
    February 7, 2002
    Date of Event
    January 29, 2002
    Report Date
    January 30, 2002
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FKX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL (HCP) REPORTS PATIENT WAS DIAGNOSED WITH PERITONITIS IN 2002. THE PATIENT'S SPOUSE CONTACTED BAXTER TECHNICAL SERVICE CENTER (TSC) DURING AUTOMATED PERITONEAL DIALYSIS (APD) THERAPY AND REPORTED THAT THE PATIENT RECEIVED AIR AND WAS EXPERIENCING PAIN IN THEIR NECK, SHOULDER AND STOMACH AREA. AT THAT TIME, BAXTER'S TECHNICIAN ADVISED CALLER TO PAUSE THERAPY AND CONTACT HCP. FOLLOW UP WITH THE HCP INDICATED THE HOME PATIENT (HP) WAS SEEN AT THE CLINIC AND NOTED TO HAVE CLOUDY EFFLUENT. A CULTURE AND SENSITIVITY WAS COLLECTED AND THE PATIENT IS CURRENTLY BEING TREATED WITH INTRAPERITONEAL CEFAZOLIN 1GM. AND FORTAZ 1GM. DAILY FOR 14 DAYS. THE PATIENT WAS ALSO ADVISED TO TAKE TYLENOL AS NEEDED FOR PAIN. HCP REPORTS SHE IS UNABLE TO VERIFY IF PATIENT RECEIVED AIR DURING TREATMENT AS NO X-RAY WAS PERFORMED. HCP REPORTS PATIENT STATUS HAS IMPROVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOMECHOICE AUTOMATED PD SET W/CASSETTE 4-PRONG HOMECHOICE CASSETTE FKX BAXTER HEALTHCARE CORPORATION NA NA01

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other HOMECHOICE AUTOMATED PD SYSTEM 115 VOLT.