BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENAL - DISPOSABLE

    MDR report key: 1850542 · Received October 1, 2010

    Report

    Report Number
    1423500-2010-03991
    Event Type
    Injury
    Date Received
    October 1, 2010
    Date of Event
    September 1, 2010
    Report Date
    September 8, 2010
    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 PATIENT DISCARDED SUPPLIES AFTER EACH THERAPY, THE SAMPLE WAS NOT REQUESTED. A 510K 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. BAXTER WILL CONTINUE TO MONITOR THESE REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    IN (B)(6)2010, THE PATIENT STARTED PERITONEAL DIALYSIS (PD) TREATMENT. ON (B)(6)2010, THE PATIENT WAS DIAGNOSED WITH PERITONITIS. THE CAUSE OF THE PERITONITIS WAS UNKNOWN. ON (B)(6)2010, THE PATIENT BEGAN REMEDIAL THERAPY WITH VANCOMYCIN (1GM, LOADING DOSE, INTRAPERITONEAL (IP), AMIKACIN (125MG, LOADING DOSE, IP) AND HEPARIN (2000 UNITS, THREE TIMES/DAY, IP). IT WAS UNKNOWN WHETHER THE PERITONITIS RESOLVED. PD THERAPY WAS ONGOING. NO CONCOMITANT MEDICATIONS WERE REPORTED. NO STATEMENT OF CAUSALITY WAS REPORTED FOR THE EVENT OF PERITONITIS.

    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 54 YR Required Intervention DIANEAL PD2 ULTRABAG