BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENAL - DISPOSABLE

    MDR report key: 1942174 · Received December 30, 2010

    Report

    Report Number
    1423500-2010-07409
    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). 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 PHYSICIAN FROM (B)(6) OF PERITONITIS IN A PATIENT (AGE AND GENDER NOT REPORTED) WHILE RECEIVING DIANEAL PD1 THERAPY. 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 ACTION TAKEN WITH DIANEAL PD1 THERAPY WAS REPORTED AS TEMPORARILY WITHDRAWN.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