BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3843987 · Received June 2, 2014

    Report

    Report Number
    1416980-2014-17682
    Event Type
    Injury
    Date Received
    June 2, 2014
    Date of Event
    May 7, 2014
    Report Date
    May 7, 2014
    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 DEVICE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN, THEREFORE, A DEVICE ANALYSIS CANNOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT THERAPY WITH VANCOMYCIN WAS COMPLETED ON EIGHT DAYS AFTER PERITONITIS WAS DIAGNOSED AND THERAPY WITH CEFTAZIDIME AND FLUCONAZOLE WAS COMPLETED ELEVEN DAYS AFTER PERITONITIS WAS DIAGNOSED. IT WAS REPORTED THAT THE PATIENT WAS RECOVERED FROM THE PERITONITIS EVENT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PERITONEAL DIALYSIS (PD) PATIENT (PT) EXPERIENCED PERITONITIS MANIFESTED BY CLOUDY EFFLUENT, ABDOMINAL PAIN AND VOMITING. THE CAUSE OF THE PERITONITIS WAS UNKNOWN. THE PT WAS NOT HOSPITALIZED FOR THE EVENT. ON THE SAME DAY AS THE ONSET OF PERITONITIS, THE PT BEGAN TREATMENT WITH VANCOMYCIN IP (2 GRAMS, EVERY 4 DAYS), CEFTAZIDIME IP (1 GRAM/DAY) IP) AND FLUCONAZOLE (50MG/DAY) ORALLY FOR PERITONITIS. THE SAME DAY, THE PT WAS RETRAINED ON PROPER ASEPTIC TECHNIQUE. TREATMENT WITH ANTIBIOTICS WAS ONGOING. AT THE TIME OF THIS REPORT, THE PT WAS RECOVERING FROM THE PERITONITIS EVENT AND PD THERAPY WAS ONGOING. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321606 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention SEVELAMER, CALCIUM ACETATE, LEVEMIR| EXTRANEAL, PHYSIONEAL 40 1.36% AND 2.27%| NOVO MIX, ERYTHROPOIETIN, FERRO GRADUMET| CINACALCET, PARICALCITOL| FUROSEMIDE, ENALAPRIL, AMLODIPINE