BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2232635 · Received September 2, 2011

    Report

    Report Number
    1423500-2011-11623
    Event Type
    Injury
    Date Received
    September 2, 2011
    Date of Event
    August 1, 2011
    Report Date
    August 15, 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 A BAXTER EMPLOYED NURSE FROM (B)(6) OF AREA NOT CLEAN BEFORE STARTING PD AND PERITONITIS IN A PATIENT COINCIDENT WITH DIANEAL PD2 ULTRABAG THERAPY. ON AN UNREPORTED DATE IN 2011, THE PATIENT DID NOT CLEAN THE AREA BEFORE STARTING PD THERAPY. ON (B)(6) 2011, THE PATIENT EXPERIENCED PERITONITIS. THE CAUSE OF THE PERITONITIS WAS DID NOT CLEAN AREA BEFORE STARTING PD. THE PATIENT WAS NOT HOSPITALIZED. ON (B)(6) 2011, THE PATIENT BEGAN REMEDIAL TREATMENT OF REFLIN (1 GM DAILY IP) AND FORTUM (1 GM DAILY IP). THE EVENT OF PERITONITIS WAS RESOLVING. IT WAS NOT REPORTED IF THE EVENT OF AREA NOT CLEAN BEFORE STARTING PD HAD RESOLVED. DIANEAL PD2 ULTRABAG THERAPY WAS ONGOING AS WAS REMEDIAL TREATMENTS WITH REFLIN AND FORTUM. THE NURSE FELT THE EVENT OF PERITONITIS WAS NOT RELATED TO DIANEAL PD2 ULTRABAG THERAPY. A CAUSALITY STATEMENT WAS NOT PROVIDED FOR THE EVENT OF AREA NOT CLEAN BEFORE STARTING PD.

    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 25 YR Required Intervention DIANEAL PD2 ULTRABAG