BEUDAMED
    FDA Adverse Event Death Summary report: N

    HOMECHOICE

    MDR report key: 3760096 · Received April 18, 2014

    Report

    Report Number
    1416980-2014-12703
    Event Type
    Death
    Date Received
    April 18, 2014
    Date of Event
    March 24, 2014
    Report Date
    March 25, 2014
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT NO: (B)(4). A SERVICE HISTORY REVIEW WILL BE PERFORMED. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS MANUFACTURED ON AN UNREPORTED DATE IN 1995. THE DEVICE WAS RECEIVED FOR EVALUATION BY THE BAXTER PRODUCT ANALYSIS LABORATORY (PAL). A REVIEW OF THE DEVICE HISTORY RECORD AND THE EVENT HISTORY LOG WAS PERFORMED. REVIEW OF THE DEVICE LOGS DID NOT REVEAL ANY ISSUES THAT COULD BE RELATED TO THE REPORTED ISSUE. THERE WERE NO KEYSTROKES, NO DEVICE FAILURE, MALFUNCTION, PROGRAMMING, USE RELATED OR IIPV (INCREASED INTRAPERITONEAL VOLUME) EVENTS THAT WOULD INDICATE AND/OR CONTRIBUTE TO THE REPORTED ISSUE. THE SERVICE HISTORY REVEALED THE DEVICE WAS SERVICED MORE THAN ONE YEAR AGO. THE DEVICE WAS EVALUATED BY PAL. A VISUAL INSPECTION WAS PERFORMED WITH NO ISSUES FOUND. THE POWER ON SELF-TEST WAS SUCCESSFULLY PERFORMED. ONE HOUR THERAPY WAS SUCCESSFULLY PERFORMED. UPON ARRIVAL THE DEVICE DID NOT MEET BAXTER SPECIFICATIONS, THUS REPAIR WAS REQUIRED. THE DEVICE WAS SERVICED ACCORDING TO REQUIRED PROCEDURES AND THE DEVICE PASSED ALL TESTS AS PER BAXTER PROCEDURES. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). PER PAL (BAXTER PRODUCT ANALYSIS LABORATORY) EVALUATION, THERE WAS NO FAILURE, MALFUNCTION OR IIPV (INCREASED INTRAPERITONEAL VOLUME) EVENT IDENTIFIED THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE OF PATIENT PASSING AWAY. THE CAUSE IS UNDETERMINED. 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 AN UNKNOWN CAUSE. THE PT WAS A RESIDENT AT AN EXTENDED CARE FACILITY AND WAS NOT HOSPITALIZED PRIOR TO DEATH. IT WAS REPORTED THAT THE PT DIED SUDDENLY. PD THERAPY WAS ONGOING UNTIL THE TIME OF DEATH AND THE PT WAS PERFORMING THERAPY AT THE TIME OF DEATH. AN AUTOPSY WAS NOT PERFORMED. ADDITIONAL INFORMATION WAS REQUESTED BUT IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236944 HOMECHOICE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1 93 YR Death 1.5% DIANEAL PD4 AMBUFLEX| EXTRANEAL| 2.5% DIANEAL PD4 AMBUFLEX