BEUDAMED
    FDA Adverse Event Death Summary report: N

    NI

    MDR report key: 23573812 · Received November 17, 2025

    Report

    Report Number
    3030306055-2025-00502
    Event Type
    Death
    Date Received
    November 17, 2025
    Date of Event
    October 11, 2025
    Report Date
    November 25, 2025
    Manufacturer
    VANTIVE US HEALTHCARE LLC
    Product Code
    KDJ
    PMA / PMN Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: B2, B5, B6, H6 AND H11. B5: UPON FOLLOW UP, IT WAS REPORTED THAT A PERITONEAL DIALYSIS (PD) PATIENT EXPERIENCED A BREACH IN ASEPTIC TECHNIQUE WHICH RESULTED IN FUNGAL PERITONITIS. THE BREACH IN ASEPTIC TECHNIQUE WAS NOT FURTHER DESCRIBED. ON AN UNKNOWN DATE, THE PATIENT WAS TREATED WITH A TABLET OF VORICONAZOLE (200MG, TWICE A DAY, ORAL, ONGOING) AND A TABLET OF METRONIDAZOLE (400MG, TWICE A DAY, ORAL, ONGOING) FOR FUNGAL PERITONITIS. THE CAUSE OF DEATH WAS REPORTED AS DUE TO FUNGAL PERITONITIS AND SEPTIC SHOCK (PREVIOUSLY REPORTED AS DUE TO SEPTIC SHOCK). IT WAS REPORTED THAT PATIENT ¿TOOK LEAVE AGAINST MEDICAL ADVICE FROM THE HOSPITAL AND DIED AT HOME¿. H11: :THIS REPORT IS FOR A BREACH IN ASEPTIC TECHNIQUE WHICH RESULTED IN PERITONITIS. PER VANTIVE LABELING, USERS ARE INSTRUCTED TO USE ASEPTIC TECHNIQUES WHEN PERFORMING PERITONEAL DIALYSIS THERAPY. 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 MANIFESTED BY CLOUDY PD EFFLUENT AND ABDOMINAL PAIN. THE CAUSE OF PERITONITIS WAS UNKNOWN. THE SAME DAY AS EVENT ONSET, THE PATIENT WAS HOSPITALIZED AND TREATED WITH CEFAZOLIN INJECTION (1G, INTRAPERITONEAL, ONGOING), AMIKACIN INJECTION (100MG, INTRAPERITONEAL, ONGOING) AND HEPARIN INJECTION (1000 IU, INTRAPERITONEAL, ONGOING) FOR PERITONITIS. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED SEPTIC SHOCK. THE CAUSE OF THE SEPTIC SHOCK WAS UNKNOWN. IT WAS REPORTED THE PATIENT PASSED AWAY ON AN UNKNOWN DATE. THE CAUSE OF DEATH WAS REPORTED AS DUE TO SEPTIC SHOCK. IT WAS NOT REPORTED IF AN AUTOPSY WAS PERFORMED. ON AN UNKNOWN DATE, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. IT WAS REPORTED THE PATIENT WAS RECOVERING FROM THE PERITONITIS EVENT AT THE TIME OF DEATH. PD THERAPY WAS ONGOING PRIOR TO AND AT THE TIME OF DEATH. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281618 NI SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ VANTIVE US HEALTHCARE LLC NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Male Death| R| H DIANEAL 1.5%.| DIANEAL 2.5%.| UNKNOWN PD CATHETER.| UNKNOWN VANTIVE PD DISPOSABLE.