BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2110857 · Received June 2, 2011

    Report

    Report Number
    1423500-2011-06946
    Event Type
    Injury
    Date Received
    June 2, 2011
    Date of Event
    April 1, 2011
    Report Date
    May 11, 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 UNDETERMINED.

    Description of Event or Problem · 1

    THIS REPORT WAS RECEIVED FROM GLOBAL PHARMACOVIGILANCE (GPV) AND IS A SPONTANEOUS REPORT BY A BAXTER-EMPLOYED NURSE FROM PORTUGAL OF BACTERIAL PERITONITIS WITH CULTURE POSITIVE FOR (B)(6) IN A PATIENT COINCIDENT WITH PHYSIONEAL 35 UNKNOWN BAG THERAPY FOR AUTOMATED PERITONEAL DIALYSIS (APD). ON (B)(6) 2011, THE PATIENT EXPERIENCED BACTERIAL PERITONITIS, MANIFESTED BY ABDOMINAL PAIN AND CLOUDY VISCOUS EFFLUENT. ON (B)(6) 2011, THE PATIENT WAS HOSPITALIZED. THE SEVERITY OF THE PERITONITIS WAS CONSIDERED SEVERE. ON AN UNREPORTED DATE THROUGH (B)(6) 2011, THE PATIENT WAS TREATED VIA IP WITH VANCOMYCIN AND CEFTAZIDIME. ON (B)(6) 2011, THE PATIENT BEGAN TREATMENT WITH AMPICILLIN 250MG IP "IN EVERY CHANGE." APPROXIMATELY ON (B)(6) 2011, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. AT THE TIME OF THIS REPORT, TREATMENT WITH AMPICILLIN WAS ONGOING AND THE PATIENT WAS RECOVERING FROM THE EVENT OF BACTERIAL PERITONITIS. THE ROOT CAUSE OF THE BACTERIAL PERITONITIS WAS A PROBABLE BREAK IN ASEPTIC TECHNIQUE. PHYSIONEAL WAS ONGOING. THE NURSE BELIEVED THE EVENT OF BACTERIAL PERITONITIS WITH CULTURE POSITIVE FOR (B)(6) WAS UNRELATED TO PHYSIONEAL 35 UNKNOWN BAG.

    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 45 YR Hospitalization| R PHYSIONEAL 35