BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2040463 · Received April 5, 2011

    Report

    Report Number
    1423500-2011-04139
    Event Type
    Injury
    Date Received
    April 5, 2011
    Date of Event
    March 1, 2011
    Report Date
    March 17, 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 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 AND IS A SPONTANEOUS REPORT BY A BAXTER-EMPLOYED NURSE FROM INDIA OF PERITONITIS COINCIDENT WITH DIANEAL PD2 ULTRABAG THERAPY. ON (B)(6) 2011, 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. THE PATIENT WAS NOT HOSPITALIZED. ON (B)(6) 2011, AN EFFLUENT CULTURE AND ANALYSIS WERE PERFORMED. THE RESULTS OF THE CULTURE WERE UNKNOWN AND THE ANALYSES WERE NOT REPORTED. ON (B)(6) 2011, THE PATIENT RECEIVED REMEDIAL TREATMENT WITH A LOADING DOSE OF REFLIN 500 GM ONCE DAILY IP AND ON THE SAME DAY, BEGAN REMEDIAL TREATMENT WITH FORTUM 1 GM ONCE DAILY IP. THE PATIENT WAS RECOVERING FROM THE PERITONITIS. REMEDIAL TREATMENT WITH REFLIN AND FORTUM WAS ONGOING. DIANEAL PD2 ULTRABAG THERAPY WAS ONGOING. THE REPORTER BELIEVED THE EVENT OF PERITONITIS WAS UNRELATED TO DIANEAL PD2 ULTRABAG 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 45 YR Required Intervention DIANEAL PD2 ULTRABAG