BEUDAMED
    FDA Adverse Event Death Summary report: N

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    MDR report key: 2083294 · Received May 10, 2011

    Report

    Report Number
    1423500-2011-05693
    Event Type
    Death
    Date Received
    May 10, 2011
    Date of Event
    April 16, 2011
    Report Date
    April 16, 2011
    Product Code
    FKX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICES INVOLVED IN THIS INCIDENT WERE UNKNOWN. AS PATIENTS DISCARD SUPPLIES AFTER EACH THERAPY, THE SAMPLE WAS NOT REQUESTED. A 510(K) NUMBER WILL NOT BE PROVIDED IN THE EMDR AS THE PRODUCT CODE AND LOT NUMBER ARE UNKNOWN. SINCE THE LOT NUMBER IS UNKNOWN, NO BATCH REVIEW WILL BE PERFORMED.

    Additional Manufacturer Narrative · 1

    (B)(4) - NO BAXTER DEVICE RELATED ROOT CAUSE COULD BE DETERMINED BECAUSE NO DEVICE PRODUCT FAILURE WAS INDICATED, NO SAMPLE WAS AVAILABLE FOR EVALUATION, AND THE DEVICES USED BY THE PATIENT ARE UNKNOWN. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    ON (B)(6) 2011, BAXTER (B)(6) RECEIVED A CALL FROM A NURSE WHO REPORTED THAT A HOME PATIENT(HP) PASSED AWAY WHILE RECEIVING PERITONEAL DIALYSIS (PD) THERAPY ON THE HOME CHOICE DEVICE. THERE WAS NO ALLEGATION OF DEVICE MALFUNCTION, AS THE NURSE REPORTED THAT THE HP WAS DOING WELL ON PD THERAPY. ON (B)(6) 2011, BAXTER (B)(6) CONTACTED A NURSE WHO STATED THAT THE CAUSE OF DEATH WAS FATAL DISSEMINATING INTRAVASCULAR COAGULATION (DIC), FATAL SEPSIS AND FATAL RENAL FAILURE. THE HP WAS IN HER 70'S. IT WAS NOT REPORTED WHETHER AN AUTOPSY WAS PERFORMED. PER THE REPORTING NURSE, THE HP HAD BEEN IN POOR CONDITION, IMMUNOCOMPROMISED AND TAKEN CARE OF AS A HOSPITAL INPATIENT BEFORE AND AT THE TIME OF DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| H LOWCAL (PD4) AMBUFLEX| EXTRANEAL| HOMECHOICE