BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENAL - DISPOSABLE

    MDR report key: 1821897 · Received August 31, 2010

    Report

    Report Number
    1423500-2010-03033
    Event Type
    Injury
    Date Received
    August 31, 2010
    Date of Event
    August 1, 2010
    Report Date
    August 10, 2010
    Manufacturer
    UNKNOWN MANUFACTURING FACILITY
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    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.

    Additional Manufacturer Narrative · 1

    (B)(4). ROOT CAUSE FOR THE PERITONITIS WAS NOT IDENTIFIED DUE TO LACK OF SAMPLE FOR EVALUATION AND INSUFFICIENT INFORMATION AVAILABLE. SINCE THE LOT NUMBER IS UNKNOWN A BATCH REVIEW COULD NOT BE PERFORMED. NO SPECIFIC PRODUCT FAILURES WERE INDICATED IN THE COMPLAINT REPORT THAT COULD CONTRIBUTE TO PERITONITIS. BAXTER HAS RECEIVED SIMILAR REPORTS FOR THE REPORTED PROBLEM AND WILL CONTINUE TO MONITOR THESE REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    THIS IS A SPONTANEOUS REPORT BY A BAXTER EMPLOYED NURSE FROM (B)(6) REGARDING PERITONITIS IN (B)(6) FEMALE HOMECHOICE PERITONEAL DIALYSIS (PD) PATIENT. ON (B)(6) 2010, THE PATIENT DEVELOPED PERITONITIS. ON (B)(6) 2010, PRIOR TO THE START OF ANTIBIOTIC THERAPY, THE PATIENT'S PERITONEAL EFFLUENT WAS ANALYZED BUT THE RESULTS WERE NOT REPORTED. ON THAT SAME DATE, A PERITONEAL EFFLUENT CULTURE RESULT WAS UNKNOWN. ON (B)(6) 2010, THE PATIENT BEGAN TREATMENT WITH AMIKACIN, REFLIN AND HEPARIN 1000 UNITS THREE TIMES DAILY INTRAPERITONEALLY. THE CAUSE OF THE PERITONITIS WAS UNKNOWN. IT WAS UNKNOWN WHETHER THE EVENT RESOLVED. THE PATIENT HAD A MEDICAL HISTORY OF END STAGE RENAL DISEASE (ESRD). THE REPORTER BELIEVED THE PERITONITIS WAS NOT RELATED TO PD THERAPY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention