BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENAL - DISPOSABLE

    MDR report key: 1821924 · Received August 31, 2010

    Report

    Report Number
    1423500-2010-03039
    Event Type
    Injury
    Date Received
    August 31, 2010
    Date of Event
    August 1, 2010
    Report Date
    August 9, 2010
    Manufacturer
    UNKNOWN MANUFACTURING FACILITY
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID
    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.

    Description of Event or Problem · 1

    THIS IS A SPONTANEOUS REPORT BY A BAXTER EMPLOYED NURSE FROM (B)(6) REGARDING PERITONITIS IN (B)(6) MALE HOMECHOICE PERITONEAL DIALYSIS (PD) PATIENT. ON (B)(6) 2010, THE PATIENT WAS DIAGNOSED WITH PERITONITIS. THE CAUSE OF THE PERITONITIS WAS A BREAK IN ASEPTIC TECHNIQUE, DESCRIBED AS THE PATIENT MADE A MISTAKE. THE DATE OF THE BREAK IN ASEPTIC TECHNIQUE WAS NOT REPORTED AND THE PATIENT WAS NOT HOSPITALIZED. NO EFFLUENT ANALYSIS OR CULTURES WERE PERFORMED. IT WAS NOT REPORTED IF THE PATIENT RECEIVED REMEDIAL THERAPY FOR THE PERITONITIS. THE OUTCOME OF THE PERITONITIS WAS UNKNOWN. PD THERAPY WAS ONGOING. MEDICAL HISTORY WAS SIGNIFICANT FOR END STAGE RENAL DISEASE (ESRD) AND HYPERTENSION.

    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 62 YR Required Intervention