BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3811894 · Received May 15, 2014

    Report

    Report Number
    1416980-2014-15561
    Event Type
    Injury
    Date Received
    May 15, 2014
    Date of Event
    April 19, 2014
    Report Date
    April 20, 2014
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AS THE SAMPLE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN, A DEVICE ANALYSIS CANNOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED PERITONITIS COINCIDENT WITH THERAPY FOR PERITONEAL DIALYSIS. THE CAUSE OF THE PERITONITIS WAS UNKNOWN. THE PATIENT WAS NOT HOSPITALIZED FOR THE EVENT. TREATMENT FOR THE EVENT INCLUDED A FORTUM INJECTION (1G, ONCE A DAY, ROUTE NOT REPORTED), VANCOMYCIN INJECTION (2G EVERY 5 DAYS, ROUTE NOT REPORTED), AND HEPARIN INJECTION (5000 IU [INTERNATIONAL UNIT], 1ML PER EXCHANGE, ROUTE NOT REPORTED). THE PATIENT WAS REPORTED TO HAVE RECOVERED FROM THE PERITONITIS. DIANEAL THERAPY AND ANTIBIOTIC TREATMENTS WERE ONGOING. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290152 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention DIANEAL PD4, 2.5% ULTRABAG