BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENAL - DISPOSABLE

    MDR report key: 1915229 · Received December 6, 2010

    Report

    Report Number
    1423500-2010-06577
    Event Type
    Injury
    Date Received
    December 6, 2010
    Date of Event
    November 1, 2010
    Report Date
    November 18, 2010
    Product Code
    KDJ
    Product Problem
    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 510(K) NUMBER WILL NOT BE PROVIDED IN THE EMDR 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. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    THIS IS A SPONTANEOUS REPORT BY A BAXTER (B)(4) FROM (B)(6) OF FEVER, LACK OF APPETITE AND PERITONITIS IN A PATIENT COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. ON (B)(6) 2010, THE PATIENT HAD A FEVER, LACK OF APPETITE AND PERITONITIS (MANIFESTED BY CLOUDY PERITONEAL EFFLUENT). ON THE SAME DAY, THE PATIENT WAS HOSPITALIZED DUE TO THE PATIENT RESIDING FAR FROM THE HOSPITAL AND THE NEED FOR REMEDIAL ANTIBIOTIC TREATMENT. ON THE SAME DAY, THE PATIENT STARTED IP TREATMENT WITH VANCOMYCIN 500MG, FREQUENCY BASED ACCORDINGLY TO SERUM VANCOMYCIN AND CEFTAZIDIME, 400MG DAILY. AT THE TIME OF THIS REPORT, THE PATIENT REMAINED HOSPITALIZED, ANTIBIOTIC TREATMENT WAS ONGOING AND THE PATIENT WAS RECOVERING FROM THE EVENT OF PERITONITIS. THE OUTCOME FOR THE EVENTS OF FEVER AND LACK OF APPETITE WAS NOT REPORTED. ACTION TAKEN WITH PD THERAPY WAS NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RENAL - DISPOSABLE SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R EXTRANEAL VIAFLEX AND PHYSIONEAL| "NORMAL MEDICATION FOR ESRD PATIENT"