BEUDAMED
    FDA Adverse Event Death Summary report: N

    NI

    MDR report key: 22687044 · Received August 1, 2025

    Report

    Report Number
    3030306055-2025-00146
    Event Type
    Death
    Date Received
    August 1, 2025
    Date of Event
    July 11, 2025
    Report Date
    August 1, 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

    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 THE PATIENT EXPERIENCED A BREACH IN ASEPTIC TECHNIQUE WHICH RESULTED IN PERITONITIS. THE BREACH IN ASEPTIC TECHNIQUE WAS NOT FURTHER DESCRIBED. THE PERITONITIS WAS MANIFESTED BY CLOUDY PD EFFLUENT, ABDOMINAL PAIN, AND WEAKNESS IN THE BODY. IT WAS REPORTED THE PATIENT WAS NOT ADMITTED TO A HOSPITAL. IT WAS REPORTED THAT THE PATIENT WAS IN "DAY CARE" AND "LEFT THE DAY CARE AGAINST MEDICAL ADVISE" ON THE SAME DAY AS DATE OF DIAGNOSIS. ON THE SAME DAY OF DIAGNOSIS, THE PATIENT WAS TREATED WITH VANCOMYCIN INJECTION (1GM, EVERY 4TH DAY, INTRAPERITONEAL) AND CEFTAZIDIME INJECTION (500MG, THREE TIMES A DAY, INTRAPERITONEAL) FOR PERITONITIS. PD THERAPY WAS ONGOING. RETRAINING FOR BREAK IN ASEPTIC TECHNIQUE WAS PERFORMED. IT WAS REPORTED THAT THE PATIENT WAS RECOVERING FROM THE EVENTS. FIVE DAYS AFTER THE DATE OF DIAGNOSIS, THE PATIENT SUBSEQUENTLY PASSED. THE CAUSE OF DEATH WAS REPORTED AS SEPSIS AND OTHER INDICATIONS. IT WAS NOT REPORTED IF AN AUTOPSY WAS PERFORMED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2277785 NI SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ VANTIVE US HEALTHCARE LLC NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Female Required Intervention| D DIANEAL 1.5%.| DIANEAL 2.5%.| TITANIUM ADAPTER.| UNKNOWN PD CATHETER.| UNSPECIFIED TRANSFER SET.