BEUDAMED
    FDA Adverse Event Other Summary report: N

    HOMECHOICE AUTOMATED PD SYSTEM 115 VOLT (REFURBISHED)

    MDR report key: 636684 · Received September 22, 2005

    Report

    Report Number
    1423500-2005-01458
    Event Type
    Other
    Date Received
    September 22, 2005
    Date of Event
    August 13, 2005
    Report Date
    August 26, 2005
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FKX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IN 08/2005, THE HP FAMILY MEMBER REPORTED THAT IN ABOUT TWO WEEKS EARLIER THE HP WAS NOT FEELING WELL AT 3:00AM. THE HP COMPLAINED OF A HEADACHE AND THE HP'S FAMILY MEMBER SUSPECTED THEY HP MAY NEED THEIR BLOOD PRESSURE MEDICINE. AT 5:30AM - 6:00AM, THE HP'S FAMILY MEMBER FOUND THE HP "PASSED OUT" ON THE FLOOR DURING APD THERAPY WHILE USING THE HOMECHOICE DIEVICE. THE HP'S FAMILY MEMBER REPORTED THAT THE DISPLAY ON THE HOMECHOICE DEVICE READ "POWER FAILURE" AND WHEN FAMILY MEMBER TURNED THE DEVICE OFF, NOTED SOME DAMPNESS AROUND THE POWER SWITCH. THE HOMECHOICE DEVICE WAS SUBSEQUENTLY REPLACED FOR SERVICING DUE TO THE POWER FAILURE. THE HP WAS ADMITTED TO THE HOSPITAL FOR HYPERTENSION AND REMAINED THERE UNTIL FOR ABOUT FIVE DAYS. THE HP RECEIVED TREATMENT VIA IV WHILE HOSPITALIZED AND WAS PRESCIRBED AVAPRO. ACCORDING TO THE HP'S FAMILY MEMBER, FAMILY MEMBER DOES NOT ATTRIBUTE THIS INCIDENT TO THE HOMECHOICE DEVICE BUT TO THE HP'S OWN HYPERTENSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOMECHOICE AUTOMATED PD SYSTEM 115 VOLT (REFURBISHED) HOMECHOICE FKX BAXTER HEALTHCARE CORPORATION 5C4471R NA

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Hospitalization| R