BEUDAMED
    FDA Adverse Event Death Summary report: N

    NI

    MDR report key: 22885884 · Received August 25, 2025

    Report

    Report Number
    3030306055-2025-00200
    Event Type
    Death
    Date Received
    August 25, 2025
    Date of Event
    June 18, 2025
    Report Date
    August 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
    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 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 PERITONEAL DIALYSIS (PD) PATIENT EXPERIENCED A BREACH IN ASEPTIC TECHNIQUE WHICH RESULTED IN PERITONITIS. THE BREACH IN ASEPTIC TECHNIQUE WAS FURTHER DESCRIBED AS "CHANGE IN CAREGIVER". THE PERITONITIS WAS MANIFESTED BY CLOUDY PD EFFLUENT AND ABDOMINAL PAIN. THE SAME DAY AS PERITONITIS ONSET, THE PATIENTS WAS HOSPITALIZED DUE TO PERITONITIS AND LATER DISCHARGED ON UNKNOWN DATE. THE PATIENT WAS TREATED WITH AN INJECTION VANCOMYCIN (1GM, ONCE EVERY 5TH DAY, INTRAPERITONEAL, ONGOING) AND INJECTION AMIKACIN (100MG, ONCE A DAY, INTRAPERITONEAL, ONGOING) FOR PERITONITIS. IT WAS NOT REPORTED IF THE PATIENT WAS RETRAINED. IT WAS REPORTED THE PATIENT PASSED AWAY AND THE CAUSE OF DEATH WAS NOT REPORTED. IT IS NOT REPORTED IF AN AUTOPSY WAS PERFORMED. IT WAS UNKNOWN IF THE PERITONITIS WAS RESOLVED PRIOR TO DEATH. IT WAS REPORTED THAT THE PD THERAPY WAS ONGOING TILL DEATH. NO ADDITIONAL INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1578559 NI SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ VANTIVE US HEALTHCARE LLC NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Female Required Intervention| H| D DIANEAL 2.5% PD2.| PD CATHETER MANUFACTURER: UNKNOWN.| UNKNOWN VANTIVE DISPOSABLE PRODUCTS.