BEUDAMED
    FDA Adverse Event Death Summary report: N

    NI

    MDR report key: 6189398 · Received December 20, 2016

    Report

    Report Number
    1416980-2016-18559
    Event Type
    Death
    Date Received
    December 20, 2016
    Report Date
    December 20, 2016
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    PMA / PMN Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ON AN UNREPORTED DATE IN (B)(6) 2016, THE PATIENT WAS DIAGNOSED WITH PERITONITIS. ON AN UNREPORTED DATE IN (B)(6) 2016, THE PATIENT PASSED AWAY. THE CAUSE OF THIS PERITONITIS WAS USE ERROR REPORTED TO BE DUE TO A BREAK IN ASEPTIC TECHNIQUE BY THE PATIENT. PER BAXTER LABELING, USERS ARE INSTRUCTED TO USE ASEPTIC TECHNIQUE WHEN PERFORMING PERITONEAL DIALYSIS THERAPY. A FORMAL REVIEW OF THE LABEL FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    A PERITONEAL DIALYSIS (PD) PATIENT EXPERIENCED A BREACH IN ASEPTIC TECHNIQUE WHICH RESULTED IN PERITONITIS AND SUBSEQUENTLY PASSED AWAY DUE TO THE EVENT. THE BREACH IN ASEPTIC TECHNIQUE WAS FURTHER DESCRIBED AS A TOUCH CONTAMINATION. THE PATIENT WAS NOT HOSPITALIZED FOR THE EVENT. ON AN UNKNOWN DATE, THE PATIENT BEGAN TREATMENT FOR THE PERITONITIS WITH INJECTION (INJ.) REFLIN AND INJ. FORTUM (1 GRAM EACH, ONCE A DAY EACH, INTRAPERITONEALLY). IT WAS REPORTED THAT THE PATIENT WAS NOT RECOVERING FROM THE PERITONITIS EVENT AND ON AN UNKNOWN DATE IN THE MONTH FOLLOWING THE DIAGNOSIS, THE PATIENT PASSED AWAY. THE CAUSE OF DEATH WAS PERITONITIS. DIANEAL AND EXTRANEAL THERAPIES WERE ONGOING UNTIL THE TIME OF DEATH. AN AUTOPSY WAS NOT PERFORMED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    839460 NI SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Death| R DIANEAL 2.5% PD4| EXTRANEAL 7.5%