BEUDAMED
    FDA Adverse Event Injury Summary report: N

    1423500-2010-04440

    MDR report key: 1871321 · Received October 15, 2010

    Report

    Report Number
    1423500-2010-04440
    Event Type
    Injury
    Date Received
    October 15, 2010
    Product Code
    KDJ
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS DISCARDED THEREFORE NO EVALUATION WAS PERFORMED. THIS INTERNATIONAL PRODUCT IS DISTRIBUTED OUTSIDE THE U.S. AND DOES NOT HAVE A 510K NUMBER, BUT IT IS BEING REPORTED AS IT IS THE SAME OR SIMILAR TO A PRODUCT DISTRIBUTED WITHIN THE U.S.

    Additional Manufacturer Narrative · 1

    (B)(4). ROOT CAUSE COULD NOT BE DETERMINED. THE LOT NUMBER WAS NOT PROVIDED, THEREFORE A BATCH REVIEW CANNOT BE CONDUCTED. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    Additional Manufacturer Narrative · 1

    (B)(4). UPON FURTHER REVIEW OF INVESTIGATION RESULTS, THIS INCIDENT HAS BEEN DETERMINED TO BE REPORTABLE AS A SERIOUS INJURY.

    Description of Event or Problem · 1

    GLOBAL PHARMACOVIGILANCE RECEIVED A REPORT FROM A (B)(6) NURSE OF A (B)(6) MALE PATIENT WHO EXPERIENCED LOOSE BOWEL MOVEMENT "LBM" (DIARRHEA), PERITONITIS AND CARDIOPULMONARY ARREST WITH DIANEAL THERAPY. ON AN UNKNOWN DATE, THE PATIENT STARTED TREATMENT WITH DIANEAL INTRAPERITONEAL (IP) FOR PERITONEAL DIALYSIS (PD). ON AN UNKNOWN DATE, THE PATIENT DEVELOPED "LOOSE BOWEL MOVEMENT" (LBM). ON (B)(6)2010, THE PATIENT WAS DIAGNOSED WITH PERITONITIS AND HOSPITALIZED. ON (B)(6)2010, THE PATIENT BEGAN TREATMENT WITH DIANEAL PD2 ULTRABAG INTRAPERITONEALLY FOR CONTINUOUS AMBULATORY PERITONEAL DIALYSIS (CAPD). THE EFFLUENT LEUCOCYTE COUNT ON (B)(6)2010 WAS 10 CELLS/MM3 WITH 29% NEUTROPHILS AND 71% LYMPHOCYTES. THE EVENT OF PERITONITIS RESOLVED IN (B)(6)2010. ON (B)(6)2010, THE PATIENT EXPERIENCED A CARDIOPULMONARY ARREST WHILE HOSPITALIZED FOR THE PERITONITIS. DIANEAL THERAPY WAS ONGOING AT THE TIME OF THE FATAL EVENT. THE REPORTER BELIEVED THAT THE EVENT OF PERITONITIS WAS NOT RELATED TO THE DIANEAL THERAPY. ADDITIONAL INFORMATION RECEIVED 09/27/10 FROM THE NEPHROLOGIST INDICATES DIANEAL PD2 ULTRABAG WAS ADDED AS SUSPECT. THE PHYSICIAN INDICATED CARDIOPULMONARY ARREST WAS NOT RELATED TO DIANEAL. IT IS UNKNOWN WHAT INTERVENTIONS WERE PROVIDED FOR THE TREATMENT OF THE PERITONITIS. IT IS UNKNOWN IF AN AUTOPSY WAS PERFORMED.

    Description of Event or Problem · 1

    HEALTH PROFESSIONAL REPORTED A "PORT EXPLANT DUE TO LEAK."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KDJ

    Patients

    Seq Age Sex Outcome Treatment
    1 DIANEAL PD4 ULTRABAG AND DIANEAL PD2 ULTRABAG