BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2091692 · Received May 17, 2011

    Report

    Report Number
    1423500-2011-06067
    Event Type
    Injury
    Date Received
    May 17, 2011
    Date of Event
    January 1, 2011
    Report Date
    April 22, 2011
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    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 510(K) NUMBER WILL NOT BE PROVIDED IN THE EMDR 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 CONDITION. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS. THE ROOT CAUSE IS UNDETERMINED.

    Description of Event or Problem · 1

    THIS IS A CLINICAL REPORT FROM (B)(6) OF CAPD PERITONITIS WITH (B)(6) IN A (B)(6) MALE SUBJECT COINCIDENT DIANEAL PD2 THERAPY. ON AN UNREPORTED DATE, THE SUBJECT BEGAN TREATMENT WITH DIANEAL PD2 5 L DAILY (LOT NUMBER UNKNOWN) INTRAPERITONEALLY (IP) FOR CONTINUOUS AMBULATORY PERITONEAL DIALYSIS (CAPD). ON (B)(6) 2011, THE SUBJECT EXPERIENCED CAPD PERITONITIS AND WAS HOSPITALIZED. ON AN UNREPORTED DATE IN 2011, DIANEAL THERAPY WAS WITHDRAWN. WHILE HOSPITALIZED, THE SUBJECT RECEIVED UNSPECIFIED TREATMENT. ON (B)(6) 2011, THE SUBJECT RECOVERED FROM THE CAPD PERITONITIS AND WAS DISCHARGED FROM THE HOSPITAL. THE INVESTIGATOR BELIEVED THAT THE CAPD PERITONITIS WAS UNRELATED TO DIANEAL THERAPY AND WAS CAUSED BY CONTAMINATION THROUGH THE SKIN. THE REPORTER DECLINED TO PROVIDE FURTHER INFORMATION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Hospitalization| R DIANEAL PD2