BEUDAMED
    FDA Adverse Event Death Summary report: N

    HOMECHOICE PRO

    MDR report key: 3873358 · Received June 13, 2014

    Report

    Report Number
    1416980-2014-19001
    Event Type
    Death
    Date Received
    June 13, 2014
    Report Date
    May 21, 2014
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS ORIGINALLY MANUFACTURED ON AN UNSPECIFIED DATE IN 2004 (PREVIOUSLY REPORTED UNDER THE PREVIOUS SERIAL NUMBER). THE DEVICE WAS NOT RETURNED; THEREFORE, AN EVALUATION COULD NOT BE CONDUCTED. A REVIEW OF THE DEVICE HISTORY RECORD FOUND THAT THE DEVICE WAS NO LONGER IN ITS ORIGINAL MANUFACTURED CONDITION; HOWEVER, THE DEVICE HAD PASSED FINAL TESTING AND CALIBRATION PRIOR TO RELEASE TO THE CUSTOMER. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Additional Manufacturer Narrative · 1

    (B)(4). A REVIEW OF THE DEVICE HISTORY RECORD FOUND THAT THE DEVICE WAS NO LONGER IN ITS ORIGINAL MANUFACTURED CONDITION; HOWEVER, THE DEVICE HAD PASSED FINAL TESTING AND CALIBRATION PRIOR TO RELEASE TO THE CUSTOMER. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THIS IS A REPORT OF A PATIENT WHO PASSED AWAY COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. IT WAS UNKNOWN IF THE PATIENT WAS HOSPITALIZED AT THE TIME OF DEATH. THE CAUSE OF DEATH WAS NOT REPORTED. IT WAS UNKNOWN IF THERAPY WAS ONGOING AT THE TIME OF DEATH. IT WAS UNKNOWN IF AN AUTOPSY WAS PERFORMED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349618 HOMECHOICE PRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1 Death