BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2222214 · Received August 24, 2011

    Report

    Report Number
    1423500-2011-11198
    Event Type
    Injury
    Date Received
    August 24, 2011
    Date of Event
    August 1, 2011
    Report Date
    August 3, 2011
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    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. THE ROOT CAUSE OF THE REPORTED CONDITION OF PERITONITIS IS USE ERROR-POOR ASEPTIC TECHNIQUE.

    Description of Event or Problem · 1

    THIS REPORT WAS RECEIVED FROM GLOBAL PHARMACOVIGILANCE (GPV) AND IS A SPONTANEOUS REPORT BY NURSE FROM (B)(6) OF THE AREA NOT BEING CLEAN BEFORE STARTING PD AND PERITONITIS IN A PATIENT COINCIDENT WITH DIANEAL PD2 ULTRABAG THERAPY FOR PERITONEAL DIALYSIS (PD). ON AN UNREPORTED DATE, THE PATIENT DID NOT CLEAN THE AREA BEFORE STARTING PD. ON (B)(6) 2011, THE PATIENT EXPERIENCED PERITONITIS. THE PATIENT WAS NOT HOSPITALIZED. THE ON AN UNREPORTED DATE, THE PATIENT BEGAN REMEDIAL THERAPY FOR THE PERITONITIS EVENT WITH TARGOCID (400 MG, IP, TWICE A DAY) AND NETMYCLIN (50 MG, IP, TWICE A DAY). IT WAS NOT REPORTED WHETHER REMEDIAL THERAPY WITH TARGOCID AND NETMYCLIN WAS ONGOING. THE EVENT OF PERITONITIS WAS RESOLVING. IT WAS NOT REPORTED IF THE PATIENT RECEIVED RE-TRAINING REGARDING ASEPTIC TECHNIQUE, THEREFORE AN OUTCOME FOR THE EVENT OF AREA NOT CLEAN BEFORE STARTING PD WAS NOT REPORTED. DIANEAL THERAPY WAS ONGOING. THE NURSE BELIEVED THAT THE EVENT OF PERITONITIS WAS UNRELATED TO DIANEAL THERAPY. THE NURSE DID NOT COMMENT ON WHETHER THE EVENT OF AREA NOT CLEAN BEFORE STARTING PD WAS RELATED TO DIANEAL THERAPY.

    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 48 YR Required Intervention DIANEAL PD2 ULTRABAG