BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENAL - DISPOSABLE

    MDR report key: 1993119 · Received February 16, 2011

    Report

    Report Number
    1423500-2011-02035
    Event Type
    Injury
    Date Received
    February 16, 2011
    Date of Event
    January 1, 2010
    Report Date
    January 26, 2011
    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 REPORT WAS RECEIVED FROM (B)(6) AND IS A SPONTANEOUS REPORT BY A NURSE FROM (B)(6) OF BACTERIAL PERITONITIS WITH (B)(6) IN A PATIENT COINCIDENT WITH DIANEAL PD2 ULTRABAG AND EXTRANEAL VIAFLEX THERAPIES FOR CONTINUOUS AMBULATORY PERITONEAL DIALYSIS (CAPD). ON AN UNKNOWN DATE IN 2010, THE PATIENT WAS DIAGNOSED WITH PERITONITIS BACTERIAL. THE CAUSE OF THE PERITONITIS WAS UNKNOWN. THE DIANEAL PD2 ULTRABAG AND THE EXTRANEAL VIAFLEX WERE WITHDRAWN AND THE PATIENT WAS TRANSFERRED TO HEMODIALYSIS ON AN UNKNOWN DATE. IT WAS UNKNOWN WHETHER THE PERITONITIS RESOLVED. THE NURSE BELIEVED THAT THE EVENT OF PERITONITIS BACTERIAL WITH (B)(6) WAS NOT RELATED TO DIANEAL THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RENAL - DISPOSABLE INITIAL MDR SUBMITTED FOR PEER REVIEW KDJ

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Other EXTRANEAL VIAFLEX| DIANEAL PD2 ULTRABAG