BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 4136943 · Received October 2, 2014

    Report

    Report Number
    1416980-2014-34227
    Event Type
    Injury
    Date Received
    October 2, 2014
    Date of Event
    September 3, 2014
    Report Date
    September 8, 2014
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CAUSE OF THIS PERITONITIS WAS USE ERROR REPORTED TO BE DUE TO A BREAK IN ASEPTIC TECHNIQUE BY THE PATIENT. PER BAXTER LABELING, USERS ARE INSTRUCTED TO USE ASEPTIC TECHNIQUE WHEN PERFORMING PERITONEAL DIALYSIS THERAPY. A FORMAL REVIEW OF THE LABEL FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT HAD A BREAK IN ASEPTIC TECHNIQUE COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY WHICH CAUSED PERITONITIS MANIFESTED BY FEVER, CHILLS, WEAKNESS, ABDOMINAL PAIN, DIARRHEA, AND VOMITING. THE CAUSE OF PERITONITIS WAS AN UNSPECIFIED USE ERROR. ON THE SAME DAY AS DIAGNOSIS, THE PATIENT WAS HOSPITALIZED FOR THE EVENT. THE PATIENT WAS TREATED (DATE UNSPECIFIED) WITH VANCOMYCIN, 2GM, INTRAPERITONEALLY (IP) X ONE DOSE AND TOBRAMYCIN, 80 MG, IP X1 DOSE FOLLOWED BY TOBRAMYCIN, 40 MG IP ONCE DAILY FOR 7 DAYS. NINE DAYS LATER, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. ON AN UNSPECIFIED DATE WITHIN THE SAME MONTH AS DIAGNOSIS, THE ANTIBIOTIC TREATMENT WAS COMPLETED, THE PATIENT WAS RETRAINED ON ASEPTIC TECHNIQUE, AND THE PATIENT WAS RECOVERED FROM THE EVENT. AT THE TIME OF THIS REPORT, DIANEAL THERAPIES WERE ONGOING FOR CONTINUOUS AMBULATORY PD. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    614526 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| R DIANEAL PD2, 1.5%, 2.5%, & 4.25%.