BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2223581 · Received August 25, 2011

    Report

    Report Number
    1423500-2011-11267
    Event Type
    Injury
    Date Received
    August 25, 2011
    Date of Event
    January 1, 2011
    Report Date
    August 7, 2011
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    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 CONSUMER WITH SUPPLEMENTAL INFORMATION BY A NURSE FROM (B)(6) OF A BREAK IN ASEPTIC TECHNIQUE AND PERITONITIS IN A PATIENT COINCIDENT WITH DIANEAL-N PD4 2.5 THERAPY FOR CHRONIC RENAL FAILURE. DURING A CALL WITH BAXTER (B)(6) TECHNICAL SERVICES, THE FOLLOWING WAS REPORTED: ON AN UNREPORTED DATE IN 2011, THE PATIENT HAD A BREAK IN ASEPTIC TECHNIQUE OCCUR DESCRIBED AS TOUCH CONTAMINATION. ON AN UNKNOWN DATE IN 2011, THE PATIENT EXPERIENCED PERITONITIS AND WAS HOSPITALIZED. IT WAS NOT REPORTED IF THE PATIENT RECEIVED ANY REMEDIAL TREATMENT OR WHETHER THE PATIENT WAS STILL HOSPITALIZED. DIANEAL-N PD4 2.5 THERAPY WAS ONGOING. IT WAS NOT REPORTED IF THE EVENTS OF BREAK IN ASEPTIC TECHNIQUE AND PERITONITIS HAD RESOLVED. THE NURSE FELT THE EVENT OF PERITONITIS WAS NOT RELATED TO DIANEAL-N PD 4 2.5 THERAPY, BUT WAS DUE TO 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 2.5