BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENAL - DISPOSABLE

    MDR report key: 1980866 · Received February 7, 2011

    Report

    Report Number
    1423500-2011-01612
    Event Type
    Injury
    Date Received
    February 7, 2011
    Date of Event
    January 1, 2011
    Report Date
    January 21, 2011
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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.

    Description of Event or Problem · 1

    THIS IS A SOLICITED REPORT BY A NURSE FROM (B)(6) OF NO GROWTH PERITONITIS IN A CHILD PATIENT (AGE NOT REPORTED) COINCIDENT WITH EXTRANEAL VIAFLEX AND PHYSIONEAL 40 (LOT NUMBERS NOT REPORTED) THERAPIES. ON AN UNREPORTED DATE, THE PATIENT BEGAN TREATMENT WITH EXTRANEAL DAILY (DOSE AND FREQUENCY NOT REPORTED) AND PHYSIONEAL 40 DAILY (DOSE AND FREQUENCY NOT REPORTED) INTRAPERITONEALLY (IP) FOR AUTOMATED PERITONEAL DIALYSIS (APD). THIS WAS OFF LABEL USE AS EXTRANEAL VIAFLEX AND PHYSIONEAL 40 WERE USED FOR A CHILD. EXTRANEAL VIAFLEX WAS BEING USED AS A DAY FILL. ON AN UNREPORTED DATE, THE PATIENT EXPERIENCED NO GROWTH PERITONITIS. ON AN UNREPORTED DATE, EXTRANEAL VIAFLEX WAS DISCONTINUED. TREATMENT AND OUTCOME WERE NOT REPORTED. PHYSIONEAL 40 THERAPY WAS ONGOING. THE PATIENT'S MEDICAL HISTORY AND CONCOMITANT MEDICATION WAS NOT REPORTED. THE REPORTER DID NOT PROVIDE AN ASSESSMENT OF CAUSALITY IN RELATION TO EXTRANEAL VIAFLEX AND PHYSIONEAL 40 THERAPIES. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    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 Other EXTRANEAL VIAFLEX| PHYSIONEAL 40