BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3950908 · Received July 22, 2014

    Report

    Report Number
    1416980-2014-23692
    Event Type
    Injury
    Date Received
    July 22, 2014
    Date of Event
    June 26, 2014
    Report Date
    June 27, 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 (PT) EXPERIENCED PERITONITIS THE CAUSE OF THE PERITONITIS WAS UNKNOWN. THE PT WAS NOT HOSPITALIZED FOR THE EVENT. ON AN UNREPORTED DATE, THE PT WAS TREATED FOR THE PERITONITIS WITH INJECTION (INJ) REFLIN (1 GRAM DAILY; ROUTE NOT REPORTED), INJ GENTAMICIN (80 MILLIGRAMS DAILY; ROUTE NOT REPORTED) AND INJ VANCOMYCIN (1 GRAM EVERY 2ND DAY; ROUTE NOT REPORTED). THE OUTCOME OF THE PERITONITIS WAS UNKNOWN. AT THE TIME OF THIS REPORT, DIANEAL THERAPY WAS ONGOING. ADDITIONAL INFORMATION IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    428588 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention DIANEAL ULTRABAG 2.5%