BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3930149 · Received July 11, 2014

    Report

    Report Number
    1416980-2014-22402
    Event Type
    Injury
    Date Received
    July 11, 2014
    Date of Event
    June 17, 2014
    Report Date
    June 17, 2014
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED PERITONITIS COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. THE CAUSE OF THE PERITONITIS WAS UNKNOWN. THE PATIENT WAS HOSPITALIZED FOR THE PERITONITIS EVENT. ON THE DAY OF ONSET, THE PATIENT WAS TREATED WITH CEFAZOLINE AND LEVOTAN (LEVOFLOXACIN) (ROUTES, DOSAGES, FREQUENCIES, AND DURATIONS NOT REPORTED) FOR THE PERITONITIS EVENT. AT THE TIME OF THIS REPORT, THE PATIENT WAS NOT RECOVERED FROM THE PERITONITIS EVENT. EXTRANEAL AND PHYSIONEAL THERAPIES WERE ONGOING. ADDITIONAL INFORMATION WAS REQUESTED BUT IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    406089 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| R CONTINUOUS AMBULATORY PERITONEAL DIALYSIS| EXTRANEAL, PHYSIONEAL 2.5%