BEUDAMED
    FDA Adverse Event Death Summary report: N

    NI

    MDR report key: 17617125 · Received August 24, 2023

    Report

    Report Number
    1416980-2023-04296
    Event Type
    Death
    Date Received
    August 24, 2023
    Report Date
    October 3, 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

    ADDITIONAL INFORMATION FOR B5: IT WAS REPORTED THAT A PATIENT EXPERIENCED A BREACH IN ASEPTIC TECHNIQUE WHICH RESULTED IN PERITONITIS. THE BREACH IN ASEPTIC TECHNIQUE WAS NOT FURTHER DESCRIBED. ON AN UNSPECIFIED DATE IN THE SAME TIME PERIOD AS THE PERITONITIS, THE PATIENT DIED. THE CAUSE OF DEATH WAS CARDIAC ARREST. ALL THE ANTIBIOTIC TREATMENT FOR PERITONITIS WAS ONGOING AND THE PATIENT HAD NOT RECOVERED FROM THE PERITONITIS AT THE TIME OF DEATH. PD THERAPY WAS ONGOING AT THE TIME OF DEATH. WAS NOT REPORTED IF AUTOPSY WILL BE PERFORMED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    A PERITONEAL DIALYSIS (PD) PATIENT EXPERIENCED PERITONITIS. THE PATIENT WAS TREATED WITH VANCOMYCIN INJECTION (1GM, INTRAPERITONEAL, EVERY 5TH DAY), FORTUM INJECTION (1GM, INTRAPERITONEAL, ONCE DAILY) AND MEROPENEM INJECTION (1GM, INTRAPERITONEAL, NIGHT DWELL) FOR PERITONITIS. PD THERAPY WAS ONGOING. THE CAUSE, HOSPITALIZATION AND PATIENT OUTCOME WERE NOT REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1006707 NI SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Male Required Intervention| D DIANEAL 2.5%