BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NI

    MDR report key: 6154758 · Received December 8, 2016

    Report

    Report Number
    1416980-2016-18173
    Event Type
    Injury
    Date Received
    December 8, 2016
    Report Date
    December 8, 2016
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    PMA / PMN Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). THIS REPORT IS FOR A BREACH IN ASEPTIC TECHNIQUE WHICH RESULTED IN PERITONITIS. PER BAXTER LABELING, USERS ARE INSTRUCTED TO USE ASEPTIC TECHNIQUE WHEN PERFORMING PERITONEAL DIALYSIS THERAPY. A REVIEW OF THE LABEL FOR THE PRODUCT FAMILY WILL BE CONDUCTED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A PERITONEAL DIALYSIS (PD) THERAPY EXPERIENCED A BREACH IN ASEPTIC TECHNIQUE WHICH RESULTED IN PERITONITIS. THE BREACH WAS NOT FURTHER SPECIFIED. ON AN UNREPORTED DATE, THE PATIENT WAS HOSPITALIZED FOR THE PERITONITIS. ON AN UNREPORTED DATE, THE PATIENT WAS TREATED WITH SALINE INTRAVENOUSLY, HEPARIN AND UNSPECIFIED ANTIBIOTICS (DOSES, FREQUENCY AND ROUTE NOT REPORTED) FOR PERITONITIS. THE PATIENT RECOVERED FROM THE PERITONITIS. IT WAS NOT REPORTED IF THE PATIENT WAS RETRAINED ON PROPER ASEPTIC TECHNIQUE. THE ACTION TAKEN WITH DIANEAL THERAPY WAS NOT REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    806582 NI SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R BAXTER PD4 2.5%