BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENAL - DISPOSABLE

    MDR report key: 1884167 · Received October 27, 2010

    Report

    Report Number
    1423500-2010-04977
    Event Type
    Injury
    Date Received
    October 27, 2010
    Date of Event
    October 1, 2010
    Report Date
    October 7, 2010
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VM
    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. BAXTER HAS RECEIVED SIMILAR REPORTS FOR THE REPORTED PROBLEM.

    Description of Event or Problem · 1

    ON (B)(6) 2005, THE PATIENT STARTED PERITONEAL DIALYSIS (PD) TREATMENT. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED A BREAK IN ASEPTIC TECHNIQUE DESCRIBED AS "THE PATIENTS HAND TOUCHED THE PATIENT CONNECTOR. ON (B)(6) 2010, THE PATIENT WAS DIAGNOSED WITH PERITONITIS MANIFESTED BY CLOUDY EFFLUENT, ABDOMINAL PAIN AND FEVER. ON (B)(6) 2010, THE PATIENT WAS HOSPITALIZED FOR THE PERITONITIS. ON THE SAME DAY, A PERITONEAL ANALYSIS AND CULTURE WAS PERFORMED. THE RESULTS OF THE PERITONEAL ANALYSIS WERE MANY LEUKOCYTES .THE RESULT OF THE CULTURE WAS NO GROWTH. ON AN UNKNOWN DATE, THE PATIENT BEGAN REMEDIAL THERAPY WITH CEFAZOLIN (1GM X 2GM, DAILY) AND GENTAMYCIN (40MG X 80MG, DAILY). PD THERAPY WAS ONGOING. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2010 AND THE PERITONITIS RESOLVED. IT WAS UNKNOWN IF THE FEVER RESOLVED. NO CONCOMITANT MEDICATIONS WERE REPORTED. THE REPORTER BELIEVED THAT THE EVENT OF PERITONITIS WAS NOT RELATED TO THE PD THERAPY. NO CAUSALITY STATEMENT WAS GIVEN FOR THE FEVER.

    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 DIANEAL PD4 ULTRABAG