BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2220760 · Received August 23, 2011

    Report

    Report Number
    1423500-2011-11108
    Event Type
    Injury
    Date Received
    August 23, 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 IS A SPONTANEOUS REPORT FROM A CONSUMER WITH SUPPLEMENTAL INFORMATION FROM A NURSE FROM (B)(6) OF PERITONITIS. ON AN UNKNOWN DATE, THE PATIENT BEGAN DIANEAL-N PD-4 2.5 THERAPY. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED A BREAK IN ASEPTIC TECHNIQUE. ON AN UNKNOWN DATE, THE PATIENT DEVELOPED PERITONITIS AND WAS ADMITTED TO THE HOSPITAL. THE PERITONEAL DIALYSIS (PD) THERAPY WAS ONGOING. PER THE NURSE, THIS EVENT WAS NOT RELATED TO PD THERAPY, BUT WAS DUE TO TOUCH-CONTAMINATION. THERE WAS NO ALLEGATION OF DEVICE MALFUNCTION. NO ADDITIONAL INFORMATION WAS PROVIDED.

    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