BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENAL - DISPOSABLE

    MDR report key: 1882139 · Received October 25, 2010

    Report

    Report Number
    1423500-2010-04914
    Event Type
    Injury
    Date Received
    October 25, 2010
    Date of Event
    October 1, 2010
    Report Date
    October 6, 2010
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    HEALTH PROFESSIONAL

    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. SINCE THE LOT NUMBER IS UNKNOWN, NO BATCH REVIEW WILL BE PERFORMED. BAXTER HAS RECEIVED SIMILAR REPORTS FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    THIS IS A SPONTANEOUS REPORT BY A BAXTER (B)(4) FROM (B)(6) OF PERITONITIS IN A PATIENT COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. ON (B)(6) 2010, THE PATIENT DEVELOPED PERITONITIS. THE CAUSE OF THE PERITONITIS WAS UNKNOWN AT THE TIME OF REPORTING. IT WAS UNKNOWN WHETHER THE PATIENT WAS HOSPITALIZED FOR THE PERITONITIS. TREATMENT FOR THE PERITONITIS INCLUDED VANCOMYCIN INJECTION (1 GM, INTRAPERITONEAL (IP), ONCE IN 4 DAYS), AMIKACIN INJECTION (500 MG IP INITIALLY THEN 250 MG IP FOR DAILY MAINTENANCE). PD THERAPY WAS ONGOING. THE OUTCOME FOR THE EVENT OF PERITONITIS WAS UNKNOWN AT THE TIME OF REPORTING.

    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 53 YR Required Intervention DIANEAL PD2 ULTRABAG