BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2221204 · Received August 24, 2011

    Report

    Report Number
    1423500-2011-11165
    Event Type
    Injury
    Date Received
    August 24, 2011
    Date of Event
    July 1, 2011
    Report Date
    August 3, 2011
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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 USE ERROR-POOR ASEPTIC TECHNIQUE.

    Description of Event or Problem · 1

    THIS REPORT WAS RECEIVED FROM GLOBAL PHARMACOVIGILANCE (GPV) AND IS A SPONTANEOUS REPORT BY A NURSE FROM (B)(6) OF A BREAK IN ASEPTIC TECHNIQUE AND PERITONITIS IN A PATIENT COINCIDENT WITH EXTRANEAL VIAFLEX, DIANEAL-N PD4 1.5% AND DIANEAL-N PD4 2.5% THERAPIES FOR CHRONIC RENAL FAILURE. ON AN UNREPORTED DATE IN 2011, A BREAK IN ASEPTIC TECHNIQUE OCCURRED DESCRIBED AS DID NOT RECAP AFTER DISCONNECTION FROM TRANSFER SET. ON (B)(6) 2011, THE PATIENT EXPERIENCED PERITONITIS. THE PATIENT WAS HOSPITALIZED ON AN UNKNOWN DATE IN 2011 FOR THE PERITONITIS. IT WAS NOT REPORTED IF THE PATIENT BEGAN ANY REMEDIAL TREATMENT FOR THE PERITONITIS. ON AN UNREPORTED DATE, THE EVENT OF PERITONITIS RESOLVED. ON (B)(6) 2011, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. IT WAS NOT REPORTED IF THE EVENT OF BREAK IN ASEPTIC TECHNIQUE RESOLVED. EXTRANEAL VIAFLEX AND DIANEAL-N THERAPIES WERE ONGOING. THE NURSE FELT THE EVENT OF PERITONITIS WAS NOT RELATED TO EXTRANEAL VIAFLEX AND DIANEAL-N THERAPIES, BUT WAS DUE TO THE EVENT OF THE BREAK IN ASEPTIC TECHNIQUE. A CAUSALITY STATEMENT WAS NOT PROVIDED FOR THE BREAK IN ASEPTIC TECHNIQUE.

    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 Hospitalization DIANEAL-N PD4 1.5%| EXTRANEAL VIAFLEX| DIANEAL-N PD4 2.5%