BEUDAMED
    FDA Adverse Event Death Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2415165 · Received January 13, 2012

    Report

    Report Number
    1423500-2012-01046
    Event Type
    Death
    Date Received
    January 13, 2012
    Date of Event
    December 1, 2011
    Report Date
    December 21, 2011
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BASED ON THE INFORMATION OBTAINED DURING BAXTER'S INVESTIGATION, THE REPORTED CONDITION COULD NOT BE CONFIRMED AND THE ROOT CAUSE COULD NOT BE DETERMINED. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THIS ISSUE IS BEING INVESTIGATED THROUGH CAPA.

    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. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THIS REPORT WAS RECEIVED FROM (B)(6) AND IS A SPONTANEOUS PHYSICIAN REPORT FROM (B)(6) OF PERITONITIS, FATAL RENAL FAILURE CHRONIC AND FATAL CARDIAC FAILURE IN A PATIENT COINCIDENT WITH EXTRANEAL VIAFLEX AND DIANEAL-N PD2 1.5% AND DIANEAL-N PD2 2.5% THERAPIES. IN (B)(6) 2011, THE PATIENT BEGAN TREATMENT WITH EXTRANEAL VIAFLEX (1500ML, ONCE A DAY), DIANEAL-N PD2 1.5% (5000ML, ONCE A DAY) AND DIANEAL-N PD2 2.5% (5000ML, ONCE A DAY) INTRAPERITONEALLY (IP) FOR RENAL FAILURE CHRONIC (RFC) ON AUTOMATED PERITONEAL DIALYSIS (APD). ON AN UNREPORTED DATE, THE PATIENT EXPERIENCED RFC AND CARDIAC FAILURE. IN (B)(6) 2011, THE PATIENT EXPERIENCED PERITONITIS. ON AN UNKNOWN DATE, THE PATIENT WAS HOSPITALIZED FOR PERITONITIS AND TREATED WITH AN UNSPECIFIED ANTIMICROBIAL MEDICATION. ON THE MORNING OF (B)(6) 2011, THE PATIENT WAS TREATED WITH HEMODIALYSIS. THAT SAME DAY, IN THE AFTERNOON, THE PATIENT EXPERIENCED SUDDEN DEATH DUE TO RFC, CARDIAC FAILURE AND THE PATIENT'S AGE. THE PERITONITIS WAS ALSO DUE TO RFC. ACTION TAKEN WITH EXTRANEAL AND DIANEAL THERAPIES PRIOR TO DEATH WAS NOT REPORTED. THE PERITONITIS HAD NOT RESOLVED AT THE TIME OF THE PATIENT'S DEATH. THE PHYSICIAN STATED THAT THE EVENTS OF PERITONITIS, FATAL RENAL FAILURE CHRONIC AND FATAL CARDIAC FAILURE WERE NOT RELATED TO DIANEAL AND EXTRANEAL THERAPIES.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Death| H| R EXTRANEAL VIAFLEX| DIANEAL-N PD2 (B)(4)| HOMECHOICE| DIANEAL-N PD2 (B)(4)