BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NI

    MDR report key: 7226448 · Received January 29, 2018

    Report

    Report Number
    1416980-2018-00427
    Event Type
    Malfunction
    Date Received
    January 29, 2018
    Date of Event
    January 3, 2018
    Report Date
    February 21, 2018
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FKX
    PMA / PMN Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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 · 1

    SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SYSTEM ERROR 2240 ALARM (AIR IN SET/LINE) OCCURRED ON A HOMECHOICE CLARIA DEVICE DURING PERITONEAL DIALYSIS THERAPY. THIS EVENT OCCURRED DURING USE. THE PATIENT WAS CONNECTED AT THE TIME OF THE ALARM. THIS INCIDENT OCCURRED WHEN THE PATIENT DETECTED WATER AT THE BOTTOM OF THE HOMECHOICE CLARIA DEVICE. THE PATIENT DETACHED THEMSELVES AND CONTINUED WITH A MANUAL CHANGE. 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
    68433 NI SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE CORPORATION NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1