BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENAL - DISPOSABLE

    MDR report key: 1941978 · Received December 30, 2010

    Report

    Report Number
    1423500-2010-07407
    Event Type
    Injury
    Date Received
    December 30, 2010
    Date of Event
    December 1, 2010
    Report Date
    December 6, 2010
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED. AS THE PATIENTS DISCARD SUPPLIES AFTER EACH THERAPY, THE SAMPLE WAS NOT REQUESTED. A 510(K) NUMBER WILL NOT BE PROVIDED IN THE EMDR AS THIS PRODUCT IS MANUFACTURED FOR DISTRIBUTION OUTSIDE OF THE U.S. AND DOES NOT HAVE A 510(K) NUMBER. HOWEVER, IT IS BEING REPORTED BECAUSE IT IS THE SAME AS OR SIMILAR TO PRODUCT DISTRIBUTED WITHIN THE U.S. BAXTER HAS RECEIVED SIMILAR REPORTS AND WILL CONTINUE TO MONITOR THESE REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    Description of Event or Problem · 1

    THIS IS A SPONTANEOUS REPORT BY A PHYSICIAN FROM (B)(4) OF PERITONITIS IN A PATIENT (AGE AND GENDER NOT REPORTED) WHILE RECEIVING DIANEAL PD1 THERAPY. THIS IS ONE OF MULTIPLE REPORTS FROM THE SAME REPORTER. ON AN UNREPORTED DATE, THE PATIENT EXPERIENCED PERITONITIS MANIFESTED BY CLOUDY DIALYSATE. TREATMENT AND OUTCOME WERE NOT REPORTED. ACTION TAKEN WITH DIANEAL PD1 THERAPY WAS REPORTED AS TEMPORARILY WITHDRAWN. PERITONEAL DIALYSIS WAS REPORTED AS ONGOING. THE REPORTER CONSIDERED THE EVENT OF PERITONITIS TO BE POSSIBLY RELATED TO DIANEAL PD1 THERAPY. ADDITIONAL INFORMATION WAS REQUESTED BUT HAD NOT BEEN RECEIVED AT THE TIME OF THIS REPORT.

    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 Required Intervention