BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NI

    MDR report key: 14597232 · Received June 3, 2022

    Report

    Report Number
    1416980-2022-02893
    Event Type
    Malfunction
    Date Received
    June 3, 2022
    Report Date
    June 17, 2022
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    PMA / PMN Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    UPDATED COMMON DEVICE NAME: REMOVE: (SYSTEM, PERITONEAL, AUTOMATIC DELIVERY). D2B: UPDATED CLASSIFICATION CODE: REMOVE: (FKX). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE MINICAP DISCONNECTED FROM THE FEMALE CONNECTOR OF THE PERITONEAL DIALYSIS (PD) TRANSFER SET. THIS CONNECTION ISSUE OCCURRED DURING THE PATIENT¿S SLEEP AND WAS NOT CONNECTED FOR PD THERAPY AT THE TIME OF THE EVENT. 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
    1031579 NI SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION NA ASKU
    1089651 NI SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Male MINICAP