BEUDAMED
    FDA Adverse Event Death Summary report: N

    RENAL - DISPOSABLE

    MDR report key: 1961968 · Received January 15, 2011

    Report

    Report Number
    1423500-2011-00682
    Event Type
    Death
    Date Received
    January 15, 2011
    Date of Event
    December 1, 2010
    Report Date
    December 21, 2010
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - ROOT CAUSE FOR THE PERITONITIS WAS NOT IDENTIFIED DUE TO LACK OF SAMPLE FOR EVALUATION AND INSUFFICIENT INFORMATION AVAILABLE. 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. BAXTER HAS RECEIVED SIMILAR REPORTS FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    THIS IS A SPONTANEOUS REPORT BY A BAXTER EMPLOYED NURSE FROM (B)(6) WHERE THE PATIENT STARTED TREATMENT WITH DIANEAL PD2 AMBUFLEX, LOT NUMBER 1010007 AND 1011012, (DOSE AND FREQUENCY WERE NOT REPORTED) INTRAPERITONEALLY (IP) FOR PERITONEAL DIALYSIS (PD). ON (B)(6) 2010, THE PATIENT WAS DIAGNOSED WITH BACTERIAL PERITONITIS, CAUSE UNKNOWN, AFTER PERITONEAL EFFLUENT ANALYSIS AND CULTURE WERE PERFORMED. VANCOMYCIN (2GM, LOADING DOSE) WAS GIVEN AND NITMYCIN (50MG, CONTINUING). DIANEAL THERAPY WAS ONGOING. IT WAS UNKNOWN IF THE PERITONITIS WAS RESOLVING. ON (B)(6) 2010, AN UPDATE THE NURSE SAID THAT THE PATIENT DIED (B)(6) 2010 FROM CARDIAC ARREST AND FATAL BACTERIAL PERITONITIS. NO STATEMENT OF CAUSALITY WAS REPORTED FOR THE EVENT OF PERITONITIS. THE DIANEAL PD2 AMBUFLEX STARTED IN (B)(6) 2010 AND FINISHED WITH THE PATIENT'S DEATH ON (B)(6) 2010. IT WAS NOT REPORTED IF THE PATIENT WAS HOSPITALIZED OR WHETHER THE PATIENT RECEIVED TREATMENT PRIOR TO THE FATAL EVENT. IT WAS NOT REPORTED WHETHER AN AUTOPSY WAS PERFORMED. THE NURSE BELIEVED THAT THE EVENTS OF CARDIAC ARREST AND PERITONITIS WERE UNRELATED TO THE DIANEAL THERAPY.

    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 68 YR Death| R DIANEAL PD2 AMBUFLEX