BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENAL - DISPOSABLE

    MDR report key: 1950019 · Received January 6, 2011

    Report

    Report Number
    1423500-2011-00165
    Event Type
    Injury
    Date Received
    January 6, 2011
    Date of Event
    December 1, 2010
    Report Date
    December 14, 2010
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    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 510(K) NUMBER WILL NOT BE PROVIDED IN THE MDR AS THE PRODUCT CODE AND LOT NUMBER ARE UNKNOWN. SINCE THE LOT NUMBER IS UNKNOWN, A BATCH REVIEW WILL NOT BE PERFORMED. BAXTER HAS RECEIVED SIMILAR REPORTS FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    THIS IS A SPONTANEOUS REPORT BY A NURSE FROM (B)(6) OF CULTURE NEGATIVE PERITONITIS WITH EXIT SITE REDNESS/ IRRITATED IN A PATIENT COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. ON (B)(6) 2010, THE PATIENT ARRIVED AT THE HOSPITAL WITH ABDOMINAL PAIN AND CLOUDY EFFLUENT. THE PATIENT WAS HOSPITALIZED FOR SUSPICION OF PERITONITIS. THE NURSE REPORTED THAT THE PATIENT'S EXIT SITE WAS RED AND IRRITATED. ON AN UNREPORTED DATE, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. INFORMATION REGARDING THE ONSET DATE, OUTCOME, AND TREATMENT FOR THE CULTURE NEGATIVE PERITONITIS WAS NOT REPORTED. ACTION TAKEN WITH EXTRANEAL THERAPY WAS NOT REPORTED. PHYSIONEAL THERAPY CONTINUED. THE REPORTER DID NOT PROVIDE AN ASSESSMENT OF CAUSALITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RENAL - DISPOSABLE SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization EXTRANEAL VIAFLEX ,PHYSIONEAL, UNSPECIFIED PRODUCT