BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2143281 · Received June 28, 2011

    Report

    Report Number
    1423500-2011-08462
    Event Type
    Injury
    Date Received
    June 28, 2011
    Date of Event
    June 1, 2011
    Report Date
    June 12, 2011
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ROOT CAUSE IS UNDETERMINED. THE DEVICE INVOLVED IN THE INCIDENT WAS 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. BAXTER HAS RECEIVED SIMILAR REPORTS FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    Description of Event or Problem · 1

    THIS REPORT WAS RECEIVED FROM GLOBAL PHARMACOVIGILANCE. THIS IS A SPONTANEOUS REPORT BY A BAXTER EMPLOYED NURSE FROM (B)(6) OF PERITONITIS COINCIDENT WITH DIANEAL PD2 ULTRABAG THERAPY. ON AN UNREPORTED DATE, THE PATIENT BEGAN TREATMENT WITH DIANEAL PD2 ULTRABAG (DOSE AND FREQUENCY NOT REPORTED) INTRAPERITONEALLY (IP) FOR PERITONEAL DIALYSIS (PD). ON (B)(6) 2011, THE PATIENT EXPERIENCED PERITONITIS. THE CAUSE OF THE PERITONITIS WAS UNKNOWN AND IT WAS UNKNOWN IF THE PATIENT WAS HOSPITALIZED. ON (B)(6) 2011, THE PATIENT BEGAN REMEDIAL THERAPY WITH FORTUM (1 GM, IP) AND VANCOMYCIN (1 GM, IP). THE OUTCOME OF THE PERITONITIS WAS UNKNOWN. THE ACTION TAKEN WITH DIANEAL PD2 ULTRABAG THERAPY WAS NOT REPORTED. THE NURSE DID NOT PROVIDE AN ASSESSMENT OF CAUSALITY.

    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 43 YR Required Intervention DIANEAL PD2 ULTRABAG