BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2020732 · Received March 16, 2011

    Report

    Report Number
    1423500-2011-03269
    Event Type
    Injury
    Date Received
    March 16, 2011
    Date of Event
    April 1, 2010
    Report Date
    February 21, 2011
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    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 SPONTANEOUS REPORT BY A NURSE FROM (B)(6) OF BACTERIAL PERITONITIS WITH (B)(6), IN A PATIENT COINCIDENT WITH DIANEAL PD2 ULTRABAG THERAPY FOR CONTINUOUS AMBULATORY PERITONEAL DIALYSIS (CAPD). ON AN UNREPORTED DATE IN 2010, THE PATIENT EXPERIENCED BACTERIAL PERITONITIS. REMEDIAL THERAPY AND WHETHER THE PATIENT WAS HOSPITALIZED WERE NOT REPORTED. THE OUTCOME FOR THE EVENT OF BACTERIAL PERITONITIS WAS NOT REPORTED. THE PATIENT WAS TRANSFERRED TO HEMODIALYSIS (REASON NOT REPORTED); THEREFORE, DIANEAL PD2 WAS WITHDRAWN. THE NURSE REPORTED THE EVENT OF BACTERIAL PERITONITIS WAS NOT RELATED TO DIANEAL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other DIANEAL PD2 ULTRABAG