BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENAL - DISPOSABLE

    MDR report key: 1905659 · Received November 23, 2010

    Report

    Report Number
    1423500-2010-06119
    Event Type
    Injury
    Date Received
    November 23, 2010
    Date of Event
    October 1, 2010
    Report Date
    November 3, 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. A BATCH REVIEW WILL NOT BE PERFORMED AS THE LOT NUMBER IS 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 AS THE PRODUCT CODE AND LOT NUMBER ARE UNKNOWN. BAXTER HAS RECEIVED SIMILAR REPORTS FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    ON (B)(6) 2007, THE PATIENT STARTED TREATMENT WITH DIANEAL PD4 UNKNOWN BAG, INTRAPERITONEALLY (IP) FOR CONTINUOUS AMBULATORY PERITONEAL DIALYSIS (CAPD). ON AN UNKNOWN DATE, A BREAK IN ASEPTIC TECHNIQUE OCCURRED. ON (B)(6) 2010, THE PATIENT WAS DIAGNOSED WITH BACTERIAL PERITONITIS MANIFESTED BY CLOUDY EFFLUENT, ABDOMINAL PAIN, AND FEVER. ON (B)(6) 2010, THE PATIENT WAS HOSPITALIZED FOR THE PERITONITIS, AND A PERITONEAL ANALYSIS AND CULTURE WERE PERFORMED. ANTIBIOTIC THERAPY WAS STARTED BUT NO FURTHER INFORMATION WAS AVAILABLE. DIANEAL THERAPY WAS ONGOING. IT WAS NOT REPORTED WHETHER THE PATIENT WAS RETRAINED; THEREFORE THE OUTCOME FOR THE EVENT OF BREAK IN ASEPTIC WAS UNKNOWN. IT WAS UNKNOWN IF THE FEVER RESOLVED. THE PERITONITIS WAS RESOLVING. THE REPORTER BELIEVED THAT THE PERITONITIS WAS DUE TO THE BREAK IN ASEPTIC TECHNIQUE. A CAUSALITY STATEMENT WAS NOT REPORTED FOR THE BREAK IN ASEPTIC TECHNIQUE OR 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 Hospitalization| R DIANEAL PD4 UNKNOWN BAG