BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENAL - DISPOSABLE

    MDR report key: 1802507 · Received August 17, 2010

    Report

    Report Number
    1423500-2010-02491
    Event Type
    Injury
    Date Received
    August 17, 2010
    Date of Event
    July 1, 2010
    Report Date
    July 29, 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 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)(4) OF PERITONITIS IN A PATIENT COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. ON (B)(6)2010, THE PATIENT WAS HOSPITALIZED AND DISCHARGED THE SAME DAY FOR PERITONITIS. ON (B)(6)2010, THE PATIENT WAS GIVEN A LOADING DOSE OF VANCOMYCIN 1GM INTRAPERITONEAL (IP), AND STARTED ON FORTUM 1GM IP ONCE DAILY AND AMIKACIN 250MG IP ONCE DAILY. IT WAS UNKNOWN IF THE EVENT OF PERITONITIS RESOLVED. AT THE TIME OF REPORTING, THE PATIENT CONTINUED WITH FORTUM AND AMIKACIN. THE ROOT CAUSE OF THE PERITONITIS WAS UNKNOWN. PD THERAPY CONTINUED.

    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 59 YR Hospitalization DIANEAL PD2 ULTRABAG AND EXTRANEAL VIAFLEX