BEUDAMED
    FDA Adverse Event Death Summary report: N

    NI

    MDR report key: 23575597 · Received November 17, 2025

    Report

    Report Number
    3030306055-2025-00508
    Event Type
    Death
    Date Received
    November 17, 2025
    Report Date
    November 17, 2025
    Manufacturer
    VANTIVE US HEALTHCARE LLC
    Product Code
    KDJ
    PMA / PMN Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    B3 EVENT DATE: THE PATIENT DEVELOPED PERITONITIS IN (B)(6) 2025. 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 FURTHER DESCRIBED AS "INCOMPLETE DISINFECTION WORK IN THE HOSPITAL WARD" AND "LACK OF STERILITY". IT WAS REPORTED THE PATIENT WAS HOSPITALIZED. TREATMENT WAS NOT REPORTED. IT WAS REPORTED THAT THE PATIENT WAS RECOVERING FROM THE PERITONITIS AND WAS DISCHARGED FROM THE HOSPITAL. IT WAS REPORTED THAT THE PATIENT "DID NOT EAT OR DRINK AND WENT INTO SHOCK MORE THAN TEN (10) DAYS LATER". THE PATIENT RECEIVED EMERGENCY TREATMENT IN THE HOSPITAL EMERGENCY ROOM. THE PATIENT SUBSEQUENTLY EXPERIENCED "ORGAN FAILURE" AND PASSED AWAY. THE CAUSE OF DEATH WAS NOT REPORTED. IT WAS NOT REPORTED IF AN AUTOPSY WAS PERFORMED. IT WAS REPORTED THE PERITONITIS WAS RESOLVING PRIOR TO DEATH. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1783107 NI SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ VANTIVE US HEALTHCARE LLC NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Female Required Intervention| D| H CLARIA AUTOMATED PD DEVICE.| DIANEAL.