BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2250229 · Received September 15, 2011

    Report

    Report Number
    1423500-2011-12276
    Event Type
    Injury
    Date Received
    September 15, 2011
    Date of Event
    July 1, 2011
    Report Date
    August 30, 2011
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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 SOLICITED REPORT BY A NURSE FROM (B)(6) OF BACTERIAL PERITONITIS WITH CULTURE POSITIVE FOR STAPHYLOCOCCUS COAGULASE NEGATIVE IN A PATIENT COINCIDENT WITH EXTRANEAL VIAFLEX THERAPY. ON (B)(6) 2011, THE PATIENT EXPERIENCED BACTERIAL PERITONITIS MANIFESTED BY CLOUDY EFFLUENT AND ABDOMINAL PAIN. THE CAUSE OF THE PERITONITIS WAS UNKNOWN. ON (B)(6) 2011, THE PATIENT BEGAN TREATMENT WITH VANCOMYCIN (1.5GM X2/EVERY DAY FOR ONE WEEK IP), GENTAMYCIN (120MG ONCE, IP) AND GENTAMYCIN (50MG X3/ EVERY DAY, IP). ON (B)(6) 2011, THE EVENT OF BACTERIAL PERITONITIS WITH CULTURE POSITIVE FOR STAPHYLOCOCCUS COAGULASE NEGATIVE RESOLVED. EXTRANEAL VIAFLEX THERAPY WAS ONGOING. CONCOMITANT MEDICATIONS WERE NOT REPORTED. THE NURSE DID NOT PROVIDE A STATEMENT OF CAUSALITY FOR THE EVENT OF BACTERIAL PERITONITIS WITH CULTURE POSITIVE FOR STAPHYLOCOCCUS COAGULASE NEGATIVE AND THE RELATIONSHIP TO EXTRANEAL VIAFLEX 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 60 YR Required Intervention EXTRANEAL VIAFLEX