BEUDAMED
    FDA Adverse Event Death Summary report: N

    NI

    MDR report key: 23294469 · Received October 15, 2025

    Report

    Report Number
    3030306055-2025-00397
    Event Type
    Death
    Date Received
    October 15, 2025
    Date of Event
    August 22, 2025
    Report Date
    November 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

    CORRECTION: B3. ADDITIONAL INFORMATION: B2, B5, H1, H6 AND H11. B5: UPON FOLLOW UP IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT PASSED AWAY AT HOME. THE CAUSE OF DEATH WAS UNKNOWN. IT WAS NOT REPORTED IF AN AUTOPSY WAS PERFORMED. IT WAS REPORTED THAT THE PERITONITIS WAS NOT RESOLVED PRIOR TO DEATH. HEMODIALYSIS THERAPY WAS ONGOING PRIOR TO 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 NOT DESCRIBED. THE PERITONITIS WAS MANIFESTED BY CLOUDY PD EFFLUENT. THE PATIENT WAS HOSPITALIZED ONE DAY AFTER EVENT ONSET. THE SAME DAY AS PERITONITIS ONSET, THE PATIENT WAS TREATED WITH INJECTION VANCOMYCIN (500MG, STAT, INTRAPERITONEAL, FOR ONE DAY), INJECTION CEFTAZIDIME (1GM, TWICE A DAY, DISCONTINUED) AND INJECTION MEROPENEM (500MG, ONCE A DAY, INTRAPERITONEAL, DISCONTINUED) FOR PERITONITIS. ON AN UNKNOWN DATE, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. AT THE TIME OF THIS REPORT, THE PATIENT WAS NOT RECOVERED FROM PERITONITIS. IT WAS REPORTED THAT THE PATIENT WAS RETRAINED ON THE PROPER ASEPTIC TECHNIQUE. ON AN UNREPORTED DATE, PERITONEAL DIALYSIS WAS PUT ON HOLD, THE PD CATHETER WAS REMOVED AND THE PATIENT SWITCHED TO HEMODIALYSIS. SAME HD IS ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2288071 NI : SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ VANTIVE US HEALTHCARE LLC NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Male Hospitalization| R| D CATHETER MANUFACTURER NAME: UNKNOWN| DIANEAL 1.5% PD2| DIANEAL 2.5% PD2| UNKNOWN VANTIVE DISPOSABLE PRODUCTS