BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NI

    MDR report key: 23002876 · Received September 9, 2025

    Report

    Report Number
    2314912-2025-00934
    Event Type
    Malfunction
    Date Received
    September 9, 2025
    Date of Event
    August 10, 2025
    Report Date
    September 9, 2025
    Manufacturer
    VANTIVE US HEALTHCARE LLC
    Product Code
    KDJ
    PMA / PMN Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    E1: INITIAL REPORTER ADDRESS: (B)(6). H11: AN ALARM INDICATIVE OF A POTENTIAL MALFUNCTION OF THE TRANSFER SET WAS REPORTED. THE DEVICE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. HOWEVER, THERE WAS A DISCONNECTION BETWEEN THE PATIENT LINE OF THE CASSETTE AND THE TRANSFER SET, WHICH IS KNOWN TO CAUSE THIS ALARM. THE CAUSE OF THE DISCONNECTION COULD NOT BE DETERMINED. 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 SYSTEM ERROR 2240 (AIR IN LINE/SET) ALARM DURING USE WITH A MINICAP TRANSFER SET. THE PATIENT WAS CONNECTED AT THE TIME OF THE ALARM. THIS OCCURRED DURING DRAIN TWO OF THREE OF PERITONEAL DIALYSIS (PD) THERAPY. DURING TROUBLESHOOTING, IT WAS REPORTED THAT THERE WAS A DISCONNECTION BETWEEN THE PATIENT LINE OF THE CASSETTE AND THE TRANSFER SET THAT LED TO THIS ALARM. RENAL THERAPY SERVICES (RTS) GUIDED THE CAREGIVER TO END THE THERAPY AND ADVISED TO CONTACT THE NURSE REGARDING THE ISSUE. RTS REVIEWED PROPER PROCEDURES PER THE USER MANUAL REVIEWED WITH THE CAREGIVER. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2333181 NI SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ VANTIVE US HEALTHCARE LLC NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown CASSETTE| HOMECHOICE CLARIA