BEUDAMED
    FDA Adverse Event Death Summary report: N

    HOMECHOICE PRO AUTOMATED PD SYSTEM 115 VOLT (REFURBISHED)

    MDR report key: 507029 · Received January 14, 2004

    Report

    Report Number
    1423500-2004-00035
    Event Type
    Death
    Date Received
    January 14, 2004
    Date of Event
    December 11, 2003
    Report Date
    December 15, 2003
    Manufacturer
    BAXTER HEALTHCARE CORP.
    Product Code
    FKX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    A HEALTHCARE PROFESSIONAL (HCP) REPORTED THAT A PATIENT (PT) EXPIRED WHILE USING THE HOMECHOICE PRO CYCLER FOR APD THERAPY. THE HCP REPORTED THAT THE PT HAD BEEN IN THE HOSPITAL SINCE BIRTH AND HAD DEVELOPED A FEVER OF 104 DEGREES F. ACCORDING TO THE HCP, DURING APD THERAPY, THE ATTENDING PHYSICIAN SUGGESTED TURNING DOWN THE DEVICE'S COMFORT CONTROL TEMPERATURE TO THE LOWEST POSSIBLE SETTING, 35 DEGREES C, IN THE HOPES THAT THIS ACTION WOULD ASSIST IN REDUCING THE PT'S BODY TEMPERATURE. THE CAUSE OF THE FEVER WAS NOT SPECIFIED, HOWEVER, ACCORDING TO THE HCP IT WAS SUSPECTED TO BE POSSIBLY RESPIRATORY OR PERITONITIS RELATED. THE PT SUBSEQUENTLY EXPIRED. NO AUTOPSY WAS PERFORMED AT THE REQUEST OF THE PT'S FAMILY. THE FACILITY HAS REFUSED TO PROVIDE FURTHER INCIDENT DETAILS; HOWEVER, SHOULD ANY ADDITION INFORMATION BECOME AVAILABLE, IT WILL BE FORWARDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 6 MO Death