BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2180377 · Received July 27, 2011

    Report

    Report Number
    1423500-2011-09807
    Event Type
    Injury
    Date Received
    July 27, 2011
    Date of Event
    July 1, 2011
    Report Date
    July 4, 2011
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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 510K NUMBER WILL NOT BE PROVIDED IN THE MDR 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. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS. THE ROOT CAUSE OF THE REPORTED CONDITION OF PERITONITIS IS UNDETERMINED.

    Description of Event or Problem · 1

    THE FOLLOWING INFORMATION WAS RECEIVED FROM GLOBAL PHARMACOVIGILANCE (GPV) AND IS A SPONTANEOUS REPORT BY A NURSE FROM (B)(6) OF FUNGAL PERITONITIS WITH CULTURE POSITIVE FOR CANDIDA PARAPSILOSIS IN A PATIENT COINCIDENT WITH EXTRANEAL VIAFLEX THERAPY. ON AN UNREPORTED DATE, THE PATIENT DEVELOPED PERITONITIS. ON (B)(6) 2011, THE PATIENT WAS HOSPITALIZED WITH A DIAGNOSIS OF PERITONITIS DUE TO CANDIDA PARAPSILOSIS. REMEDIAL MEDICATION AND DIAGNOSTIC TESTS WERE UNKNOWN. ON AN UNREPORTED DATE IN 2011, THE PATIENT'S PD CATHETER WAS REMOVED AND THE PATIENT WAS SWITCHED TO HEMODIALYSIS. THE NURSE REPORTED BECAUSE THE PATIENT WAS VERY ILL THEY REMAINED HOSPITALIZED. THE PATIENT HAD NOT RECOVERED FROM THE PERITONITIS OR THE EVENT OF VERY ILL. THE NURSE BELIEVED THAT THE PERITONITIS AND EVENT OF VERY ILL WAS POSSIBLY RELATED TO DIANEAL AND EXTRANEAL VIAFLEX THERAPIES. THIS IS ONE OF SEVERAL REPORTS RECEIVED FROM THE SAME REPORTER. FOLLOW-UP INFORMATION ((B)(4) 2011): THE EVENT OF PERITONITIS DUE TO CANDIDA PARAPSILOSIS WAS AMENDED TO FUNGAL PERITONITIS WITH CULTURE POSITIVE FOR CANDIDA PARAPSILOSIS. ON (B)(6) 2011, THE PATIENT EXPERIENCED FUNGAL PERITONITIS, MANIFESTED BY EXTREME ABDOMINAL PAIN AND CLOUDY EFFLUENT. THE ROOT CAUSE OF THE FUNGAL PERITONITIS WAS UNKNOWN. REMEDIAL THERAPY CONSISTED OF CEFAZOLIN (1.5 GM, DAILY FOR 4 DAYS, IP), TOBRAMYCIN (50 MG, DAILY, IP), FLUCONAZOLE (200 MG, DAILY FOR 4 WEEKS, ORAL) AND VANCOMYCIN (1 GM, ONCE ON (B)(6) 2011, IP). ON (B)(6) 2011, THE PATIENT'S PD CATHETER WAS REMOVED AND THE PATIENT WAS SWITCHED TO HEMODIALYSIS. THE FUNGAL PERITONITIS AND EVENT OF VERY ILL WERE RESOLVING AND THE PATIENT REMAINED HOSPITALIZED. IT WAS UNKNOWN TO THE REPORTER WHETHER THE EVENTS WERE RELATED TO EXTRANEAL VIAFLEX THERAPY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Hospitalization EXTRANEAL VIAFLEX| DIANEAL UNKNOWN