BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3962052 · Received July 28, 2014

    Report

    Report Number
    1416980-2014-24514
    Event Type
    Injury
    Date Received
    July 28, 2014
    Date of Event
    June 16, 2014
    Report Date
    July 3, 2014
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT NO: (B)(4). THE CAUSE OF THIS PERITONITIS WAS USE ERROR REPORTED TO BE DUE TO A BREAK IN ASEPTIC TECHNIQUE. 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. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THIS IS A REPORT OF A PATIENT WHO EXPERIENCED A BREACH IN ASEPTIC TECHNIQUE RESULTING IN PERITONITIS COINCIDENT WITH CONTINUOUS AMBULATORY PERITONEAL DIALYSIS (CAPD) THERAPY. THE PERITONITIS WAS MANIFESTED BY ABDOMINAL PAIN, CLOUDY EFFLUENT AND EFFLUENT WITH ELEVATED WHITE COUNT. THE PATIENT WAS NOT HOSPITALIZED FOR THE EVENT. ON THE SAME DAY, THE PATIENT BEGAN TREATMENT WITH INTRAPERITONEAL (IP) VANCOMYCIN FOR PERITONITIS AND IP GENTAMYCIN FOR CLOUDY EFFLUENT, (DOSE AND FREQUENCIES NOT REPORTED). NINETEEN DAYS LATER, TREATMENT WITH GENTAMYCIN WAS DISCONTINUED, AND ON AN UNKNOWN DATE, TREATMENT WITH VANCOMYCIN WAS DISCONTINUED. DIANEAL THERAPY WAS ONGOING. THE PATIENT WAS REPORTED TO HAVE BEEN RECOVERING FROM THIS OCCURRENCE OF PERITONITIS. TWENTY-TWO DAYS AFTER THE FIRST ONSET OF PERITONITIS, THE PATIENT EXPERIENCED RECURRENT PERITONITIS MANIFESTED BY ABDOMINAL PAIN, CLOUDY EFFLUENT AND EFFLUENT WITH ELEVATED WHITE BLOOD CELL COUNT. ON THE SAME DAY, THE PATIENT AGAIN STARTED TREATMENT WITH IP VANCOMYCIN FOR PERITONITIS AND IP GENTAMYCIN FOR CLOUDY EFFLUENT, (DOSE AND FREQUENCIES NOT REPORTED). DIANEAL THERAPY WAS STILL ONGOING. ON AN UNREPORTED DATE, THE PATIENT WAS RETRAINED IN ASEPTIC TECHNIQUE. AT THE TIME OF THIS REPORT, TREATMENT WITH VANCOMYCIN AND GENTAMYCIN WERE ONGOING, AND THE PATIENT WAS NOT RECOVERED FROM THE EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    437492 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention DIANEAL 2.5% PD4 ULTRABAG