BEUDAMED
    FDA Adverse Event Death Summary report: N

    CXD II

    MDR report key: 1941650 · Received December 30, 2010

    Report

    Report Number
    1423500-2010-07394
    Event Type
    Death
    Date Received
    December 30, 2010
    Date of Event
    December 1, 2010
    Report Date
    December 7, 2010
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    KDJ
    PMA / PMN Number
    K851208
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - AS THE DATE OF ONSET OF THIS PERITONITIS EPISODE IS UNKNOWN AND PATIENTS DISCARD SUPPLIES AFTER EACH THERAPY, THE SAMPLE WAS NOT REQUESTED. THIS IS THE SECOND OF FOUR COMPLAINTS ASSOCIATED WITH THIS EVENT.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED AND THE SERIAL NUMBER IS UNKNOWN THEREFORE AN EVALUATION WAS NOT PERFORMED. THE ROOT CAUSE OF THIS INCIDENT WAS UNDETERMINED. BAXTER HAS RECEIVED SIMILAR REPORTS FOR THE REPORTED CONDITION. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    Description of Event or Problem · 1

    ON AN UNREPORTED DATE, THE PATIENT BEGAN TREATMENT WITH DIANEAL PD4 AMBUFLEX. DURING A CALL WITH BAXTER CUSTOMER SERVICES, THE CONSUMER STATED THAT ON AN UNREPORTED DATE, THE PATIENT EXPERIENCED CARDIAC FAILURE AND ON (B)(6) 2010, DIED. TREATMENT INFORMATION WAS NOT PROVIDED PRIOR TO DEATH. IT WAS NOT REPORTED WHETHER AN AUTOPSY WAS PERFORMED. DIANEAL THERAPY WAS ONGOING AT THE TIME OF THE PATIENT'S DEATH. THE PATIENT'S CONCOMITANT MEDICATIONS WERE NOT REPORTED. CAUSAL RELATIONSHIP WAS NOT REPORTED FOR THE EVENT OF FATAL CARDIAC FAILURE AND DIANEAL PD4 AMBUFLEX THERAPY. FURTHER INFORMATION WAS OBTAINED 15DEC2010 FROM THE DIALYSIS NURSE. ACCORDING TO THE CHART, THE CAUSE OF DEATH WAS NOTED AS COMPLICATIONS DUE TO FUNGAL PERITONITIS. ACCORDING TO THE NURSE, THE EVENT OF FATAL COMPLICATIONS DUE TO FUNGAL PERITONITIS WAS NOT RELATED TO DIANEAL PD4 AMBUFLEX THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CXD II SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Death| O DIANEAL PD4 AMBUFLEX