BEUDAMED
    FDA Adverse Event Death Summary report: N

    RENAL - DISPOSABLE

    MDR report key: 1913164 · Received December 2, 2010

    Report

    Report Number
    1423500-2010-06461
    Event Type
    Death
    Date Received
    December 2, 2010
    Date of Event
    November 1, 2010
    Report Date
    November 9, 2010
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ROOT CAUSE COULD NOT BE DETERMINED. BAXTER HAS RECEIVED SIMILAR REPORTS FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THIS IS A SPONTANEOUS REPORT BY A CONSUMER WITH SUPPLEMENTAL INFORMATION BY A NURSE FROM INDIA OF PERITONITIS AND FATAL CARDIAC ARREST IN A (B)(6) FEMALE PATIENT COINCIDENT WITH DIANEAL PD2 ULTRABAG THERAPY. ON (B)(6) 2010, THE PATIENT STARTED TREATMENT WITH DIANEAL PD2 ULTRABAG DOSE AND FREQUENCY NOT REPORTED) INTRAPERITONEALLY (IP) FOR PERITONEAL DIALYSIS (PD). ON (B)(6) 2010, THE PATIENT WAS DIAGNOSED WITH PERITONITIS AND WAS ADMITTED TO THE HOSPITAL. A PERITONEAL EFFLUENT CULTURE WAS PERFORMED; HOWEVER, RESULTS WERE NOT REPORTED. ON (B)(6) 2010, THE PATIENT BEGAN TREATMENT WITH REFLIN 1 GRAM IP ONCE DAILY, FORTUM 1 GRAM IP ONCE DAILY AND HEPARIN 1000 UNITS IP THREE TIMES DAILY; WITH THERAPY REPORTED AS CONTINUING. THE CAUSE OF THE PERITONITIS WAS NOT REPORTED. DIANEAL THERAPY WAS REPORTED AS ONGOING. ADDITIONAL INFORMATION OBTAINED ON 11NOV2010 IS AS FOLLOWS: 2010): ON (B)(6) 2010, THE PATIENT EXPERIENCED A CARDIAC ARREST AND DIED. THE CAUSE OF DEATH WAS REPORTED TO BE CARDIAC ARREST. IT WAS NOT REPORTED WHETHER AN AUTOPSY WAS PERFORMED. DIANEAL THERAPY WAS ONGOING AT THE TIME OF THE PATIENT'S DEATH. THE EVENT OF PERITONITIS WAS NOT RESOLVED PRIOR TO THE PATIENT'S DEATH. THE NURSE CONSIDERED THE EVENTS OF PERITONITIS AND FATAL CARDIAC ARREST TO BE UNRELATED TO DIANEAL PD 2 THERAPY. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RENAL - DISPOSABLE SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Death| H DIANEAL PD2 ULTRABAG