BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2183463 · Received July 28, 2011

    Report

    Report Number
    1423500-2011-09959
    Event Type
    Injury
    Date Received
    July 28, 2011
    Date of Event
    July 1, 2011
    Report Date
    July 11, 2011
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    NURSE

    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

    THE FOLLOWING INFORMATION WAS RECEIVED FROM GLOBAL PHARMACOVIGILANCE (GPV) AND IS A SPONTANEOUS REPORT BY A NURSE FROM (B)(6) OF BACTERIAL PERITONITIS WITH CULTURE POSITIVE FOR ENTEROBACTERIA IN A PATIENT COINCIDENT WITH DIANEAL UNKNOWN, DIANEAL PD2 AMBUFLEX, DIANEAL PD2 ULTRABAG, DIANEAL PD4 ULTRABAG, AND EXTRANEAL VIAFLEX THERAPIES. ON (B)(6) 2011, THE PATIENT EXPERIENCED BACTERIAL PERITONITIS. THE CAUSE OF THE PERITONITIS WAS UNKNOWN. ON (B)(6) 2011, THE PATIENT WAS HOSPITALIZED FOR THE BACTERIAL PERITONITIS. ON (B)(6) 2011, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. IN (B)(6) 2011, THE PATIENT RECOVERED FROM THE BACTERIAL PERITONITIS. THE ACTION TAKEN WITH DIANEAL AND EXTRANEAL THERAPIES WAS NOT REPORTED. THE REPORTER BELIEVED THAT THE BACTERIAL PERITONITIS WAS UNRELATED TO DIANEAL AND EXTRANEAL THERAPIES.

    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 53 YR Hospitalization DIANEAL PD2| DIANEAL UNKNOWN,| DIANEAL PD2 AMBUFLEX,