BEUDAMED
    FDA Adverse Event Death Summary report: N

    NI

    MDR report key: 23705733 · Received December 3, 2025

    Report

    Report Number
    3030306055-2025-00559
    Event Type
    Death
    Date Received
    December 3, 2025
    Date of Event
    November 7, 2025
    Report Date
    December 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

    THIS REPORT IS FOR A BREACH IN ASEPTIC TECHNIQUE WHICH RESULTED IN PERITONITIS. PER BAXTER 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 NOT FURTHER DESCRIBED. THE PERITONITIS WAS MANIFESTED BY CLOUDY PD EFFLUENT AND ABDOMINAL PAIN. IT WAS REPORTED THE PATIENT WAS HOSPITALIZED ON THE NEXT DAY OF PERITONITIS DIAGNOSIS AND TREATED WITH VANCOMYCIN INJECTION (1G, EVERY 5TH DAY, INTRAPERITONEAL, DISCONTINUED), AMIKACIN INJECTION (125MG, ONCE DAILY, INTRAPERITONEAL, DISCONTINUED) AND MEROPENEM INJECTION (1G, ONCE DAILY, INTRAPERITONEAL, DISCONTINUED) FOR PERITONITIS. IT WAS REPORTED THAT THE PATIENT PASSED AWAY WHILE IN THE HOSPITAL. THE CAUSE OF DEATH WAS REPORTED TO BE FUNGAL INFECTION. IT WAS NOT REPORTED IF AN AUTOPSY WAS PERFORMED. IT WAS REPORTED THE PERITONITIS WAS NOT RESOLVED PRIOR TO DEATH. PD THERAPY WAS DISCONTINUED PRIOR TO DEATH AND SHIFTED TO HD TILL THE DEATH OF PATIENT. IT WAS REPORTED RETRAINING ON THE PROPER ASEPTIC TECHNIQUE WAS DONE. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2854193 NI SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ VANTIVE US HEALTHCARE LLC NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Male Death| H| R DIANEAL 1.5%.| DIANEAL 2.5%.| EXTRANEAL 7.5%.| UNKNOWN PD CATHETER.| UNKNOWN VANTIVE PD DISPOSABLE.