BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2981190 · Received February 27, 2013

    Report

    Report Number
    1416980-2013-04805
    Event Type
    Injury
    Date Received
    February 27, 2013
    Date of Event
    January 10, 2013
    Report Date
    February 5, 2013
    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). THIS REPORT OF PERITONITIS WAS RECEIVED WITH NO ALLEGED DEVICE MALFUNCTION OR USE ERROR; THEREFORE, A SAMPLE WAS NOT REQUESTED. SINCE THE LOT NUMBER IS UNKNOWN, NO BATCH REVIEW WILL BE PERFORMED. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED. THE PROBLEM WAS NOT CONFIRMED. NO DEVICE MALFUNCTION OR USE ERROR WAS IDENTIFIED. NO ASSIGNABLE CAUSE WAS DETERMINED.

    Additional Manufacturer Narrative · 1

    (B)(4). ON (B)(4) 2013, FOLLOW UP INFORMATION WAS RECEIVED RELATED TO THIS EVENT. IT WAS REPORTED THAT THE PATIENT RECOVERED FROM THE PERITONITIS AND RE-INITIATED PERITONEAL DIALYSIS THERAPY. SHOULD RELEVANT ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED AND WAS HOSPITALIZED FOR PERITONITIS COINCIDENT WITH THERAPIES FOR END STAGE RENAL DISEASE (ESRD). THE PATIENT EXPERIENCED CLOUDY EFFLUENT AS A RESULT OF THE PERITONITIS. THE PATIENT WAS TREATED WITH CEFTAZIDIME, VANCOMYCIN, AND IMIPENEM FOR THE PERITONITIS. ON A LATER DATE, ANTIBIOTIC THERAPY WITH IMIPENEM AND VANCOMYCIN WAS SUSPENDED AND GENTAMICIN WAS STARTED. THE PATIENT ALSO BEGAN TREATMENT WITH CIPROFLOXACIN AND DAILY DOSAGES OF FLUCONAZOLE WERE INCREASED. THE PATIENT'S CATHETER WAS REPLACED AT THE SAME TIME THERAPY WITH CEFTAZIDIME AND GENTAMICIN ENDED. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. AT THE TIME OF THIS REPORT, ORAL TREATMENT WITH CIPROFLOXACIN AND FLUCONAZOLE WAS ONGOING. PERITONEAL DIALYSIS WAS TEMPORALLY SUSPENDED AND THE PATIENT WAS UNDER ANALYTICAL SURVEILLANCE, ENABLING THE PERITONEAL HEALING. AT THE TIME OF THIS REPORT, THE PATIENT WAS RECOVERING FROM THE EVENT OF PERITONITIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    84312 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization| R ABACAVIR, LAMIVUDINE, ATAZANAVIR, RITONAVIR,| DARBEPOETIN ALFA, CLOPIDOGREL, CALCITRIOL, NOVOLET| AMLODIPINE, FUROSEMIDE, FOLIC ACID, DOMPERIDONE,| EXTRANEAL AND PHYSIONEAL 2.27%| CALCIUM CARBONATE| OMEPRAZOLE, FERRO GRADUMET, VIGANTO