BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2212746 · Received August 16, 2011

    Report

    Report Number
    1423500-2011-10758
    Event Type
    Injury
    Date Received
    August 16, 2011
    Date of Event
    July 1, 2011
    Report Date
    July 28, 2011
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    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 SOLICITED REPORT BY A BAXTER EMPLOYED NURSE IN (B)(6) OF A BREAK IN ASEPTIC TECHNIQUE AND PERITONITIS WITH CULTURE POSITIVE FOR (B)(6) IN A PATIENT, COINCIDENT WITH EXTRANEAL VIAFLEX (IMPORTED FROM USA) AND PHYSIONEAL 40 UNKNOWN BAG THERAPIES FOR AMBULATORY PERITONEAL DIALYSIS (APD). ON AN UNREPORTED DATE, A BREAK IN ASEPTIC TECHNIQUE OCCURRED. ON (B)(6) 2011, THE PATIENT EXPERIENCED PERITONITIS, MANIFESTED BY ABDOMINAL PAIN. THE CAUSE OF THE PERITONITIS WAS THE BREAK IN ASEPTIC TECHNIQUE. THE PATIENT WAS NOT HOSPITALIZED. THE PATIENT BEGAN REMEDIAL THERAPY WITH VANCOMYCIN (2G, IP). THE PATIENT WAS RECOVERING FROM THE PERITONITIS. IT WAS NOT REPORTED IF THE BREAK IN ASEPTIC TECHNIQUE HAD RESOLVED. EXTRANEAL AND PHYSIONEAL THERAPIES WERE ONGOING. THE NURSE BELIEVED THAT THE EVENT OF PERITONITIS WITH CULTURE POSITIVE FOR (B)(6) WAS NOT RELATED TO EXTRANEAL AND PHYSIONEAL THERAPIES. A CAUSALITY STATEMENT WAS NOT PROVIDED FOR THE BREAK IN ASEPTIC TECHNIQUE.

    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 78 YR Required Intervention EXTRANEAL VIAFLEX (IMPORTED FROM USA)| PHYSIONEAL 40 UNKNOWN BAG