BEUDAMED
    FDA Adverse Event Death Summary report: N

    NI

    MDR report key: 16378197 · Received February 15, 2023

    Report

    Report Number
    1416980-2023-00487
    Event Type
    Death
    Date Received
    February 15, 2023
    Date of Event
    January 19, 2023
    Report Date
    February 15, 2023
    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
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    A PERITONEAL DIALYSIS (PD) PATIENT EXPERIENCED A BREACH IN ASEPTIC TECHNIQUE WHICH RESULTED IN PERITONITIS. THE BREACH IN ASEPTIC TECHNIQUE WAS NOT FURTHER DESCRIBED. A DAY PRIOR TO THE PERITONITIS DIAGNOSIS, THE PATIENT WAS HOSPITALIZED DUE TO ABDOMINAL PAIN AND FEVER. ON THE SAME DAY AS THE PERITONITIS DIAGNOSIS, THE PATIENT WAS TREATED WITH INTRAVENOUS AND INTRAPERITONEAL VANCOMYCIN INJECTION (500MG, ONGOING) AND AMIKACIN INJECTION (250MG, ONGOING) FOR PERITONITIS. THREE DAYS AFTER THE PERITONITIS DIAGNOSIS, THE PATIENT PASSED AWAY. THE CAUSE OF DEATH WAS REPORTED AS DUE TO PERITONITIS. IT WAS UNKNOWN IF AN AUTOPSY WAS PERFORMED. IT WAS REPORTED PD THERAPY WAS ONGOING AT THE TIME OF DEATH. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1204830 NI SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Male Required Intervention| D| H DIANEAL 2.5%| EXTRANEAL 7.5%| UNKNOWN BAXTER PD DISPOSABLES| UNKNOWN PD CATHETER