BEUDAMED
    FDA Adverse Event Death Summary report: N

    HOMECHOICE PRO

    MDR report key: 2863431 · Received December 10, 2012

    Report

    Report Number
    1416980-2012-06816
    Event Type
    Death
    Date Received
    December 10, 2012
    Date of Event
    November 12, 2012
    Report Date
    November 16, 2012
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED FOR EVALUATION. THEREFORE, THE REPORTED CONDITION COULD NOT BE CONFIRMED AND A CAUSE COULD NOT BE DETERMINED. A REVIEW OF SERVICE DATA REVEALED THERE IS NO PREVIOUS SERVICE HISTORY FOR THIS DEVICE. A DEVICE HISTORY REVIEW WAS ALSO PERFORMED WITH NO ABNORMALITIES NOTED.

    Additional Manufacturer Narrative · 1

    (B)(4). A REQUEST FOR THE RETURN OF THE DEVICE HAS BEEN MADE. SHOULD THE DEVICE BE RECEIVED BY BAXTER FOR EVALUATION, A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF AN EVALUATION OR IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED FROM GLOBAL PHARMCOVIGILANCE (GPV) OF THE DEATH OF A HOMECHOICE HOME PATIENT (HP). A HOUSE SITTER HAD MENTIONED, DURING A SUPPLY PICK UP BY HOME CARE SERVICES (HCSR), THAT THE HP HAD EXPIRED ON (B)(6) 2012, AND THAT FAMILY WAS ATTENDING THE FUNERAL WHILE SHE WAS WATCHING THE HOME. PRODUCT SURVEILLANCE MADE CONTACT WITH THE PERITONEAL DIALYSIS (PD) NURSE ON (B)(4) 2012 REGARDING THE REPORTED INCIDENT. THE NURSE HAS DECLINED TO PROVIDE ANY INFORMATION REGARDING THE REPORTED INCIDENT. NO ADDITIONAL INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOMECHOICE PRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Death (B)(4) DIANEAL LOW CA 4.25% DEX 5L/6L| (B)(4) DIANEAL LOW CAL 1.5% DEX 5L/| (B)(4) DIANEAL LOW CAL 2.5% DEX 5L/6L