BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2231359 · Received September 1, 2011

    Report

    Report Number
    1423500-2011-11569
    Event Type
    Injury
    Date Received
    September 1, 2011
    Date of Event
    August 1, 2011
    Report Date
    August 12, 2011
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EZ
    Reporter Occupation
    PHYSICIAN

    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.

    Description of Event or Problem · 1

    THIS REPORT WAS RECEIVED FROM GLOBAL PHARMACOVIGILANCE (GPV) AND IS A SOLICITED REPORT BY A PHYSICIAN FROM (B)(6) OF PERITONITIS IN A PATIENT COINCIDENT WITH IMPORTED DIANEAL PD4 UNKNOWN BAG THERAPY FOR RENAL INSUFFICIENCY. ON (B)(6) 2011, THE PATIENT EXPERIENCED PERITONITIS AFTER APPLICATION OF DIANEAL PD4. ON (B)(6) 2011, THE PATIENT BEGAN REMEDIAL THERAPY AT HOME WITH UNSPECIFIED ANTIBIOTIC; HOWEVER THE REMEDIAL THERAPY WAS NOT SUCCESSFUL. ON (B)(6) 2011, THE PATIENT WAS HOSPITALIZED. ON AN UNREPORTED DATE, THE PERITONEAL DIALYSIS (PD) CATHETER WAS EXTRACTED AND THE PATIENT WAS SWITCHED TO HEMODIALYSIS. AT THE TIME IF THIS REPORT, REMEDIAL THERAPY WAS ONGOING AND THE PATIENT REMAINED HOSPITALIZED. THE OUTCOME FOR THE EVENT OF PERITONITIS WAS REPORTED AS NOT RECOVERED. DIANEAL PD4 THERAPY WAS PERMANENTLY WITHDRAWN. THE PHYSICIAN REPORTED THAT THE EVENT OF PERITONITIS WAS RELATED TO DIANEAL PD4 THERAPY.

    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 Hospitalization| R DIANEAL PD4 UNKNOWN