BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2212739 · Received August 16, 2011

    Report

    Report Number
    1423500-2011-10754
    Event Type
    Injury
    Date Received
    August 16, 2011
    Date of Event
    June 1, 2011
    Report Date
    July 27, 2011
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    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 FROM (B)(6) OF PERITONITIS WITH CULTURE POSITIVE FOR (B)(6) IN PATIENT COINCIDENT WITH PHYSIONEAL 40 CLEARFLEX THERAPY FOR PERITONEAL DIALYSIS (PD). ON (B)(6) 2011, THE PATIENT PRESENTED WITH ABDOMINAL PAIN AND CLOUDY BAGS AND WAS DIAGNOSED WITH PERITONITIS. THE OUTCOME OF THE PERITONITIS WAS NOT REPORTED. PHYSIONEAL THERAPY WAS ONGOING. THE REPORTER DID NOT PROVIDE AN ASSESSMENT OF CAUSALITY. THIS IS ONE OF SEVERAL REPORTS RECEIVED FROM THE SAME REPORTER.

    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 Other PHYSIONEAL 40 CLEARFLEX