BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2192396 · Received August 5, 2011

    Report

    Report Number
    1423500-2011-10296
    Event Type
    Injury
    Date Received
    August 5, 2011
    Date of Event
    January 1, 2011
    Report Date
    July 18, 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

    THIS REPORT WAS RECEIVED FROM GLOBAL PHARMACOVIGILANCE (GPV) AND IS A SPONTANEOUS REPORT BY A NURSE IN (B)(6) OF BACTERIAL PERITONITIS WITH CULTURE POSITIVE FOR (B)(6) IN A PATIENT COINCIDENT WITH DIANEAL PD4 ULTRABAG AND EXTRANEAL VIAFLEX THERAPIES FOR CONTINUOUS AMBULATORY PERITONEAL DIALYSIS (CAPD). IN 2011, THE PATIENT EXPERIENCED BACTERIAL PERITONITIS. THE CAUSE OF THE PERITONITIS WAS UNKNOWN. TREATMENT FOR THE EVENT WAS NOT REPORTED. IT WAS NOT REPORTED IF THE BACTERIAL PERITONITIS HAD RESOLVED. IT WAS NOT REPORTED IF DIANEAL AND EXTRANEAL THERAPIES WERE ONGOING. THE NURSE BELIEVED THE BACTERIAL PERITONITIS WAS NOT RELATED 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 47 YR Other EXTRANEAL VIAFLEX| DIANEAL PD4 ULTRABAG