BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2102796 · Received May 25, 2011

    Report

    Report Number
    1423500-2011-06465
    Event Type
    Injury
    Date Received
    May 25, 2011
    Date of Event
    May 1, 2011
    Report Date
    May 2, 2011
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    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. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS. THE ROOT CAUSE OF THE REPORTED CONDITION OF PERITONITIS IS UNDETERMINED.

    Additional Manufacturer Narrative · 1

    (B)(4). ON AN UNREPORTED DATE, REMEDIAL THERAPY WAS DISCONTINUED. IT WAS NOT REPORTED IF THE EVENT OF PERITONITIS HAD RESOLVED. THE CAUSE OF DEATH WAS FATAL CARDIAC DISEASE. IT WAS NOT REPORTED IF THE PATIENT WAS HOSPITALIZED PRIOR TO HIS DEATH, IF AN AUTOPSY WAS PERFORMED OR IF REMEDIAL THERAPY WAS RENDERED. DIANEAL PD2 ULTRABAG THERAPY WAS NOT DISCONTINUED PRIOR TO THE PATIENT'S DEATH. THE CONSUMER CONSIDERED THE EVENT OF FATAL CARDIAC DISEASE TO BE UNRELATED TO DIANEAL PD2 ULTRABAG THERAPY.

    Description of Event or Problem · 1

    THIS REPORT WAS RECEIVED FROM GLOBAL PHARMACOVIGILANCE (GPV) AND IS A SPONTANEOUS REPORT BY A CONSUMER FROM (B)(6) OF CHRONIC URINARY TRACT INFECTION (UTI) AND PERITONITIS IN A PATIENT COINCIDENT WITH DIANEAL PD2 ULTRABAG THERAPY FOR PERITONEAL DIALYSIS (PD). ON (B)(6) 2011, THE PATIENT EXPERIENCED PERITONITIS. IT WAS NOT REPORTED IF THE PATIENT REQUIRED HOSPITALIZATION. THE CAUSE OF THE PERITONITIS WAS CHRONIC UTI. ON (B)(6) 2011, THE PATIENT BEGAN REMEDIAL THERAPY WITH CEFTAZIDIME (1GM, TWICE DAILY, IP) AND VANCOMYCIN (1GM, WEEKLY, IP). THE CONSUMER DID NOT PROVIDE AN ASSESSMENT OF CAUSALITY FOR THE EVENTS OF PERITONITIS AND CHRONIC UTI. FOLLOW-UP INFORMATION REVEALED THE PATIENT PASSED AWAY (B)(6) 2011. THE CAUSE OF DEATH WAS CARDIAC DISEASE.

    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 66 YR Required Intervention DIANEAL PD2 ULTRABAG