BEUDAMED
    FDA Adverse Event Death Summary report: N

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    MDR report key: 3944640 · Received July 18, 2014

    Report

    Report Number
    1416980-2014-23285
    Event Type
    Death
    Date Received
    July 18, 2014
    Date of Event
    June 19, 2014
    Report Date
    June 23, 2014
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FKX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AS THE DEVICE WAS NOT LINKED TO THE REPORTED DEATH UNTIL AFTER THE DEVICE HAD BEEN SERVICED, A COMPLETE DEVICE EVALUATION COULD NOT BE COMPLETED TO INVESTIGATE THE REPORTED DEATH. HOWEVER, A REVIEW OF THE DEVICE LOGS REVEALED NO SYSTEM ERRORS, ANOMALIES, HARDWARE DEVICE FAILURES OR INCREASED INTRAPERITONEAL VOLUME (IIPV) EVENTS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED DEATH. THE EVENT HISTORY LOG REVIEW SHOWED NO KEYSTROKES, PROGRAMMING, OR USE RELATED EVENTS THAT INDICATED AND/OR CONTRIBUTED TO THE HOME PATIENT PASSING AWAY. A REVIEW OF THE SERVICE HISTORY REVEALED NO PREVIOUS SERVICE EVENTS THAT WOULD CAUSE OR CONTRIBUTE TO THE REPORTED PROBLEM. THE CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED. 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 FOLLOW-UP WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PERITONEAL DIALYSIS (PD) PATIENT (PT), WHO PERFORMED PD THERAPY WITH A HOMECHOICE (HC) DEVICE, PASSED AWAY DUE TO HEART FAILURE. TWELVE DAYS PRIOR TO DEATH, THE PT WAS HOSPITALIZED WITH AN ADMITTING DIAGNOSIS OF HEART FAILURE. TREATMENT DURING HOSPITALIZATION WAS UNKNOWN. IT WAS NOT REPORTED WHETHER THE PT WAS CONNECTED TO THE HC AT THE TIME OF DEATH OR IF PD THERAPY WAS ONGOING UNTIL THE TIME OF DEATH. IT WAS UNKNOWN IF AN AUTOPSY WAS PERFORMED. NO FURTHER INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION WAS REQUESTED BUT IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    422636 SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Death| H DIANEAL PD4 1.5% 2.5% AMBUFLEX