BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3971865 · Received July 31, 2014

    Report

    Report Number
    1416980-2014-24924
    Event Type
    Injury
    Date Received
    July 31, 2014
    Date of Event
    July 8, 2014
    Report Date
    July 8, 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). THE DEVICE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN, THEREFORE, A DEVICE ANALYSIS CANNOT BE COMPLETED. THE CAUSE IS NOT IDENTIFIED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PERITONEAL DIALYSIS (PD) PATIENT EXPERIENCED PERITONITIS. THE CAUSE OF PERITONITIS WAS UNKNOWN. ON THE SAME DAY AS ONSET, THE PATIENT WAS HOSPITALIZED FOR THE EVENT. ON AN UNREPORTED DATE, THE PATIENT WAS TREATED FOR THE PERITONITIS WITH UNSPECIFIED MEDICATION (DOSE, FREQUENCY AND ROUTE OF ADMINISTRATION NOT REPORTED). AT THE TIME OF THIS REPORT, THE PERITONITIS WAS RESOLVING, THE PATIENT WAS RECOVERING, AND DIANEAL THERAPIES WERE ONGOING. ADDITIONAL INFORMATION WAS REQUESTED BUT IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    446441 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Hospitalization| R DIANEAL 2.5% ULTRABAG| DIANEAL 1.5% ULTRABAG