BEUDAMED
    FDA Adverse Event Death Summary report: N

    NI

    MDR report key: 22212639 · Received June 16, 2025

    Report

    Report Number
    3030306055-2025-00042
    Event Type
    Death
    Date Received
    June 16, 2025
    Date of Event
    May 24, 2025
    Report Date
    July 28, 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.

    Additional Manufacturer Narrative · 0

    B5: UPON FOLLOW UP, IT WAS REPORTED THAT MEROPENEM WAS DISCONTINUED ON AN UNKNOWN DATE. IT WAS REPORTED THAT THE PATIENT SUBSEQUENTLY PASSED AWAY IN THE HOSPITAL. THE CAUSE OF DEATH WAS REPORTED AS DUE TO LOW BLOOD PRESSURE. IT WAS NOT REPORTED IF AN AUTOPSY WAS PERFORMED. IT WAS REPORTED THAT THE PATIENT HAD NOT RECOVERED FROM THE PERITONITIS PRIOR TO DEATH. HD THERAPY WAS ONGOING. 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 NOT FURTHER DESCRIBED. THE PERITONITIS WAS MANIFESTED BY CLOUDY PD EFFLUENT. THE SAME DAY AS EVENT ONSET, THE PATIENT WAS HOSPITALIZED AND TREATED WITH VANCOMYCIN INJECTION (1GM, EVERY 96 HOURS, INTRAPERITONEAL, FOR SEVEN DAYS) AND MEROPENEM INJECTION (1GM, ONCE DAILY, INTRAPERITONEAL, FOR SEVEN DAYS) FOR PERITONITIS. EIGHT DAYS AFTER EVENT ONSET, THE PATIENT WAS TREATED WITH INJECTION OF MEROPENEM )1 GM EVERY 96 HOURS, INTRAVENOUS, ONGOING). TEN DAYS AFTER HOSPITAL ADMISSION, THE PATIENT WAS DISCHARGED. AT THE TIME OF THIS REPORT, THE PATIENT WAS NOT RECOVERED FROM THE PERITONITIS. SEVEN DAYS AFTER EVENT ONSET, PD THERAPY WAS STOPPED. THE PD CATHETER WAS REMOVED AND THE PATIENT WAS SHIFTED TO HEMODIALYSIS (ONGOING). IT WAS REPORTED THE PATIENT WAS RETRAINED ON THE PROPER ASEPTIC TECHNIQUE. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1540366 NI SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ VANTIVE US HEALTHCARE LLC NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Female Required Intervention| H| D COVIDIEN PD CATHETER.| DIANEAL 1.5% PD2.| DIANEAL 2.5% PD2.| UNKNOWN VANTIVE PD DISPOSABLES.