BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2180037 · Received July 27, 2011

    Report

    Report Number
    1423500-2011-09723
    Event Type
    Injury
    Date Received
    July 27, 2011
    Date of Event
    June 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

    THIS REPORT WAS RECEIVED FROM (B)(6) AND IS A SPONTANEOUS REPORT BY A NURSE FROM (B)(6) OF FUNGAL PERITONITIS WITH (B)(6) AND A PATIENT BEING VERY SICK COINCIDENT WITH EXTRANEAL VIAFLEX THERAPY FOR CONTINUOUS AMBULATORY PERITONEAL DIALYSIS (CAPD). THIS IS ONE OF MULTIPLE REPORTS BY THE SAME REPORTER. ON AN UNREPORTED DATE, THE PATIENT EXPERIENCED BEING VERY SICK AND ON (B)(6) 2011, THE PATIENT EXPERIENCED FUNGAL PERITONITIS, MANIFESTED BY EXTREME ABDOMINAL PAIN AND CLOUDY EFFLUENT. ON (B)(6) 2011, THE PATIENT WAS TREATED WITH TOBRAMYCIN 45MG IP ONE TIME ONLY. FROM (B)(6) 2011 THROUGH (B)(6) 2011, THE PATIENT WAS TREATED WITH TOBRAMYCIN 40MG/DAY IP. ON (B)(6) 2011, THE PATIENT WAS HOSPITALIZED FOR BEING VERY SICK AND FUNGAL PERITONITIS, WHICH WAS CONSIDERED SERIOUS. ON AN UNREPORTED DATE, THE PATIENT WAS TREATED WITH CEFAZOLIN 1GM/DAY IP FOR 4 DAYS, CIPRO 500MG/DAY ORALLY FOR 10 DAYS AND FLUCONAZE 200MG/DAY ORALLY FOR 4 WEEKS. ON (B)(6) 2011, THE PD CATHETER WAS REMOVED DUE TO THE FUNGAL PERITONITIS AND THE PATIENT WAS TRANSFERRED TO HEMODIALYSIS. THE HOSPITAL ANALYZED THEIR OWN ENVIRONMENT, WHICH INCLUDED A CULTURE PERFORMED ON THEIR WATER, SINK, UNIT WALL, ETC. THE CULTURE REVEALED NEGATIVE RESULTS AT THIS TIME. ON (B)(6) 2011, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. AT THE TIME OF THIS REPORT, THE PATIENT WAS RECOVERING FROM THE EVENTS OF FUNGAL PERITONITIS AND VERY SICK. THE NURSE BELIEVED THAT THE EVENTS OF PERITONITIS CAUSED BY CANDIDA "TARAPSILOSIS" AND VERY SICK WAS POSSIBLY RELATED TO DIANEAL AND EXTRANEAL VIAFLEX THERAPIES. THE ROOT CAUSE OF THE FUNGAL PERITONITIS WAS UNKNOWN.

    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 62 YR Hospitalization| R EXTRANEAL VIAFLEX