BEUDAMED
    FDA Adverse Event Death Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3840452 · Received May 30, 2014

    Report

    Report Number
    1416980-2014-17345
    Event Type
    Death
    Date Received
    May 30, 2014
    Report Date
    May 5, 2014
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). APPROXIMATELY SIX WEEKS PRIOR TO PASSING AWAY, THE PATIENT EXPERIENCED CHEST PAIN AND WAS HOSPITALIZED ON THE SAME DAY FOR THE EVENT. ON AN UNKNOWN DATE WHILE HOSPITALIZED, THE PATIENT HAD DEFIBRILLATOR PLACEMENT. ON AN UNKNOWN DATE WHILE HOSPITALIZED, THE DEFIBRILLATOR PLACEMENT SITE BECAME INFECTED. THE INFECTION FROM THE DEFIBRILLATOR SITE LED TO SEPSIS WHICH WAS THE CAUSE OF DEATH. IT WAS REPORTED THAT THE PATIENT HAD NOT EXPERIENCED PERITONITIS (PREVIOUSLY REPORTED). UPON FURTHER INVESTIGATION, IT WAS DETERMINED THAT BAXTER DISPOSABLES AND DEVICE WERE NO LONGER SUSPECT PRODUCTS FOR THE CAUSE OF DEATH. 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

    IT WAS REPORTED THAT A PERITONEAL DIALYSIS (PD) PATIENT (PT) ACQUIRED PERITONITIS AND SUBSEQUENTLY PASSED AWAY. THE CAUSE OF DEATH WAS REPORTED TO BE SEPSIS. THE CAUSE OF THE PERITONITIS EVENT WAS UNKNOWN. ON AN UNKNOWN DATE PRIOR TO DEATH, THE PT WAS HOSPITALIZED. THE TREATMENT FOR THE PERITONITIS WAS UNKNOWN. IT WAS UNKNOWN IF PD THERAPY WAS ONGOING UNTIL THE TIME OF DEATH. IT WAS UNKNOWN IF AN AUTOPSY WAS PERFORMED. ADDITIONAL INFORMATION WAS REQUESTED BUT IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318205 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| H HOMECHOICE| DIANEAL 1.5% AND 2.5% PD4 AMBUFLEX