BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENAL - DISPOSABLE

    MDR report key: 1973064 · Received January 28, 2011

    Report

    Report Number
    1423500-2011-01215
    Event Type
    Injury
    Date Received
    January 28, 2011
    Date of Event
    July 1, 2010
    Report Date
    July 2, 2010
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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. FOLLOW UP WILL BE SUBMITTED IF INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    THIS IS A REPORT OF A PATIENT FROM BAXTER (B)(4) WHO CONTRACTED PERITONITIS. NO OTHER INFORMATION WAS OBTAINED AT THE TIME OF THE INITIAL PHONE CALL AND THE REPORTER REFUSED FOLLOW UP BY BAXTER PRODUCT SAFETY. NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE CONCERNING PATIENT DEMOGRAPHICS, EVENT DETAILS, RESOLUTION, TREATMENT, MEDICAL HISTORY, RESULTS OF TESTING, PERITONEAL PRESCRIPTION AND CONCOMITANT MEDICATION THERAPY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 66 Other