BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2061690 · Received April 18, 2011

    Report

    Report Number
    1423500-2011-04659
    Event Type
    Injury
    Date Received
    April 18, 2011
    Date of Event
    March 1, 2011
    Report Date
    March 26, 2011
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    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 510(K) NUMBER WILL NOT BE PROVIDED IN THE EMDR 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 CONDITION. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    Description of Event or Problem · 1

    THIS IS A SOLICITED REPORT BY A BAXTER EMPLOYED NURSE FROM (B)(4) OF BREAK IN ASEPTIC TECHNIQUE, BACTERIAL PERITONITIS WITH CULTURE POSITIVE FOR STAPHYLOCOCCUS EPIDERMIDIS, NAUSEA AND VOMITING IN A (B)(6) PATIENT COINCIDENT WITH EXTRANEAL VIAFLEX AND PHYSIONEAL 40 UNKNOWN BAG THERAPIES. IN (B)(6) 2011, THE PATIENT BEGAN TREATMENT WITH EXTRANEAL VIAFLEX 2 LITERS DAILY AND PHYSIONEAL 40 UNKNOWN BAG 6 LITERS DAILY FOR CAPD (CONTINUOUS AMBULATORY PERITONEAL DIALYSIS). IT WAS REPORTED THAT EXTRANEAL AND PHYSIONEAL 40 WERE DELIVERED TO THE PATIENT. ON AN UNREPORTED DATE, A BREAK IN ASEPTIC TECHNIQUE OCCURRED. ON (B)(6) 2011, THE PATIENT EXPERIENCED BACTERIAL PERITONITIS MANIFESTED BY NAUSEA, VOMITING, ABDOMINAL PAIN AND CLOUDY PERITONEAL EFFLUENT. ON (B)(6) 2011, THE PATIENT WAS HOSPITALIZED FOR THE PERITONITIS. ON AN UNREPORTED DATE, THE PATIENT WAS TREATED WITH UNSPECIFIED ANTIBIOTICS. IT WAS NOT REPORTED IF TREATMENT HAD CONTINUED. ON (B)(6) 2011, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. ON AN UNREPORTED DATE, THE PATIENT RECOVERED FROM THE PERITONITIS. THE OUTCOME OF THE NAUSEA AND VOMITING WAS NOT REPORTED. IT WAS NOT REPORTED IF THE PATIENT WAS RETRAINED IN ASEPTIC TECHNIQUE, THEREFORE, THE OUTCOME IS UNKNOWN. EXTRANEAL VIAFLEX AND PHYSIONEAL 40 UNKNOWN THERAPY WERE REPORTED AS ONGOING. THE NURSE BELIEVED THE EVENT OF PERITONITIS WAS UNRELATED TO EXTRANEAL AND PHYSIONEAL THERAPY, HOWEVER, DID NOT PROVIDE AN OPINION OF CAUSALITY FOR THE EVENTS OF NAUSEA, VOMITING AND BREAK IN ASEPTIC TECHNIQUE. THE NURSE REPORTED THAT THE CAUSE OF THE PERITONITIS WAS DUE TO 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 CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| R PHYSIONEAL 40 UNKNOWN BAG| EXTRANEAL VIAFLEX