BEUDAMED
    FDA Adverse Event Death Summary report: N

    NI

    MDR report key: 22709300 · Received August 4, 2025

    Report

    Report Number
    3030306055-2025-00150
    Event Type
    Death
    Date Received
    August 4, 2025
    Date of Event
    July 14, 2025
    Report Date
    September 3, 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, H1, AND H6. B5: UPON FOLLOW UP, IT WAS REPORTED THAT ON AN UNKNOWN DATE THE PATIENT EXPERIENCED PULMONARY EDEMA AND CARDIAC ARREST. THE PATIENT PASSED AWAY 5 DAYS AFTER THE DIAGNOSIS OF PERITONITIS. THE CAUSE OF DEATH WAS REPORTED TO BE PULMONARY EDEMA AND CARDIAC ARREST. IT WAS NOT REPORTED IF AN AUTOPSY WAS PERFORMED. PD THERAPY WAS REPORTED TO BE ONGOING TILL THE EVENT OF DEATH. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS FOR A BREACH IN ASEPTIC TECHNIQUE WHICH RESULTED IN PERITONITIS. PER VANTIVE 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

    IT WAS REPORTED THAT A PATIENT EXPERIENCED A BREACH IN ASEPTIC TECHNIQUE WHICH RESULTED IN PERITONITIS. THE BREACH IN ASEPTIC TECHNIQUE WAS FURTHER DESCRIBED AS "CHANGE IN CARETAKER". THE PERITONITIS WAS MANIFESTED BY CLOUDY PD EFFLUENT. ON THE SAME DATE AS DIAGNOSIS, THE PATIENT WAS HOSPITALIZED AND BEGAN TREATMENT WITH VANCOMYCIN INJECTION (1GM, EVERY 3 DAYS, INTRAPERITONEAL, ONGOING) AND AMAKACIN INJECTION (150MG, ONCE DAILY, INTRAVENOUS, ONGOING) FOR PERITONITIS. AT THE TIME OF THIS REPORT, THE PATIENT REMAINS HOSPITALIZED AND WAS RECOVERING FROM THE PERITONITIS. PD THERAPY IS ONGOING. RETRAINING FOR THE CHANGE IN CARETAKER WAS DONE. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2448860 NI SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ VANTIVE US HEALTHCARE LLC NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Male Death| H| R DIANEAL 2.5%.| EXTRANEAL 7.5%.| UNKNOWN PD CATHETER.| UNKNOWN VANTIVE PD DISPOSABLE.