BEUDAMED
    FDA Adverse Event Death Summary report: N

    HOMECHOICE, DOMESTIC 120V

    MDR report key: 1882116 · Received October 25, 2010

    Report

    Report Number
    1423500-2010-04898
    Event Type
    Death
    Date Received
    October 25, 2010
    Date of Event
    September 30, 2010
    Report Date
    September 30, 2010
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K053512
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER CAREGIVERS

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED TO BAXTER PRODUCT ANALYSIS LAB (PAL) FOR EVALUATION. A VISUAL INSPECTION WAS PERFORMED. NO PROBLEMS WERE ENCOUNTERED OR REVEALED DURING THE INSPECTION PROCESS. THE POWER ON SELF TEST TO THE DEVICE WAS PERFORMED SUCCESSFULLY. UPON FURTHER INVESTIGATION, NO MALFUNCTIONS WERE FOUND. A ONE HOUR THERAPY WAS PERFORMED SUCCESSFULLY WITH NO ISSUES ENCOUNTERED. NO FAILURES WERE IDENTIFIED THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. THE ASSIGNABLE CAUSE FOR THE REPORTED ISSUE WAS UNDETERMINED. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Additional Manufacturer Narrative · 1

    (B)(4).UPON COMPLETION OF THE INVESTIGATION OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER ASSISTANCE TO HAVE THE HOME PATIENT'S (HP) HOMECHOICE (HC) UNIT PICKED UP. THE CARE GIVER (CG) REQUESTED BAXTER PICK UP THE HC AND REQUESTED THE BALANCE OF THE HP'S UNUSED SUPPLIES. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) REFERRED THE CG TO CALL BAXTER (B)(4) TO ARRANGE FOR THE HC AND SUPPLIES TO BE RETURNED. THE REASON FOR THE RETURN OF THE HC AND SUPPLIES WAS THAT THE HP PASSED AWAY. THE CALL WAS COMPLETED AND THE HC WAS OPERATIONAL. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOMECHOICE, DOMESTIC 120V SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1