BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2250098 · Received September 15, 2011

    Report

    Report Number
    1423500-2011-12268
    Event Type
    Injury
    Date Received
    September 15, 2011
    Date of Event
    August 1, 2011
    Report Date
    August 30, 2011
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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 UNDETERMINED.

    Description of Event or Problem · 1

    THE FOLLOWING INFORMATION WAS RECEIVED FROM GLOBAL PHARMACOVIGILANCE (GPV) AND IS A SPONTANEOUS REPORT BY A NURSE FROM (B)(6) OF VANCOMYCIN RESISTANT ENTEROCOCCI PERITONITIS IN A PATIENT COINCIDENT WITH DIANEAL PD4 AMBUFLEX (DIANEAL PD4 SYS II WITH 1.5% AND 2.5% GLUCOSE) AND EXTRANEAL VIALFLEX THERAPIES. ON (B)(6) 2011, THE PATIENT EXPERIENCED VANCOMYCIN RESISTANT ENTEROCOCCI PERITONITIS AND WAS HOSPITALIZED. THE PATIENT'S CATHETER WAS REMOVED AND PD THERAPY WAS DISCONTINUED. IT WAS UNKNOWN IF THE EVENT OF VANCOMYCIN RESISTANT ENTEROCOCCI PERITONITIS RESOLVED. DIANEAL AND EXTRANEAL THERAPIES WERE PERMANENTLY DISCONTINUED. THE NURSE BELIEVED THAT IT WAS UNLIKELY THAT THE EVENT OF VANCOMYCIN RESISTANT ENTEROCOCCI WAS RELATED TO DIANEAL AND EXTRANEAL THERAPIES.

    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 81 YR Hospitalization DIANEAL PD4 AMBUFLEX| EXTRANEAL VIALFLEX