BEUDAMED
    FDA Adverse Event Death Summary report: N

    HOMECHOICE

    MDR report key: 3943614 · Received July 18, 2014

    Report

    Report Number
    1416980-2014-23207
    Event Type
    Death
    Date Received
    July 18, 2014
    Date of Event
    June 23, 2014
    Report Date
    June 24, 2014
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

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

    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 ANALYSIS 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 INTRAPERITONEAL VOLUME IIPV EVENTS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED DIFFICULTY. REVIEW OF THE DEVICE SERVICE HISTORY AND DEVICE HISTORY RECORD REVEALED NO ISSUES THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE HOME PATIENT PASSING AWAY. 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 DEATH COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY ON THE HOMECHOICE (HC). THE PATIENT WAS NOT HOSPITALIZED PRIOR TO DEATH. IT WAS REPORTED THE PATIENT WAS PERFORMING AUTOMATED PERITONEAL DIALYSIS (APD) PRIOR TO DEATH; HOWEVER, IT IS UNKNOWN IF THE PATIENT WAS CONNECTED TO THE HC DEVICE AT THE TIME OF DEATH. THE CAUSE OF DEATH WAS UNKNOWN. IT WAS NOT REPORTED IF AN AUTOPSY WAS PERFORMED. ADDITIONAL INFORMATION WAS REQUESTED, BUT IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    422875 HOMECHOICE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Death EXTRANEAL SOLUTION| DIANEAL LOW CALCIUM 1.5% SINGLEBAG| DIANEAL LOW CALCIUM 2.5% SINGLEBAG