BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2000881 · Received February 24, 2011

    Report

    Report Number
    1423500-2011-02426
    Event Type
    Injury
    Date Received
    February 24, 2011
    Date of Event
    January 1, 2011
    Report Date
    February 3, 2011
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    OTHER

    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.

    Description of Event or Problem · 1

    THIS IS A REPORT BY A BAXTER HOMECARE NURSE FROM (B)(6) OF "POSSIBLE BREAK IN ASEPTIC TECHNIQUE" AND PERITONITIS WITH (B)(6) IN A PATIENT COINCIDENT WITH EXTRANEAL VIAFLEX AND PHYSIONEAL, UNSPECIFIED PRODUCT THERAPIES. ON (B)(6) 2008, THE PATIENT BEGAN TREATMENT WITH EXTRANEAL VIAFLEX, 2 LITERS DAILY (LOT NUMBER NOT REPORTED) AND PHYSIONEAL UNSPECIFIED PRODUCT, 12.5 LITERS DAILY (LOT NUMBER NOT SPECIFIED) INTRAPERITONEALLY (IP) FOR APD (AUTOMATED PERITONEAL DIALYSIS). ON AN UNREPORTED DATE, THE PATIENT EXPERIENCED A "POSSIBLE BREAK IN ASEPTIC TECHNIQUE". ON (B)(6) 2011, THE PATIENT EXPERIENCED ABDOMINAL PAIN, AND CLOUDY PERITONEAL AFFLUENT. ON THAT SAME DAY, THE PATIENT "WENT TO THE HOSPITAL", HOWEVER, WAS NOT HOSPITALIZED. ON (B)(6) 2011, THE PATIENT WAS DIAGNOSED WITH PERITONITIS. ON (B)(6) 2011, THE PATIENT RECEIVED CEFTAZIDIME 1 GRAM IP DAILY AND CEFAZOLIN 1 GRAM IP, PER HOSPITAL PROTOCOL. EXTRANEAL VIAFLEX AND PHYSIONEAL, WERE TEMPORARILY WITHDRAWN. AT OF THE TIME OF THIS REPORT, THE EVENT OF PERITONITIS WAS REPORTED AS RESOLVING. IT WAS NOT REPORTED IF THE PATIENT WAS RETRAINED IN ASEPTIC TECHNIQUE. CONCOMITANT MEDICATIONS WERE NOT REPORTED. THE NURSE DID NOT PROVIDE A CAUSALITY ASSESSMENT FOR THE EVENTS OF "POSSIBLE BREAK IN ASEPTIC TECHNIQUE", AND PERITONITIS WITH (B)(6). THE NURSE REPORTED "THE PERITONITIS WAS POSSIBLY DUE TO THE BREAK IN ASEPTIC TECHNIQUE". THE PERITONITIS WAS REPORTED AS MODERATE IN SEVERITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention EXTRANEAL VIAFLEX| PHYSIONEAL