BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    MDR report key: 4123415 · Received September 26, 2014

    Report

    Report Number
    1416980-2014-33495
    Event Type
    Malfunction
    Date Received
    September 26, 2014
    Date of Event
    September 1, 2014
    Report Date
    September 1, 2014
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AN ALARM INDICATIVE OF A POTENTIAL MALFUNCTION OF THE DISPOSABLE CASSETTE WAS IDENTIFIED. AS THE CASSETTE WAS DISCARDED AND THE LOT NUMBER IS UNKNOWN, A DEVICE ANALYSIS CANNOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS AN ALARM ON THE HOMECHOICE (HC). THE PATIENT CHECKED THE ALARM LOG AND FOUND THAT IT WAS A SYSTEM ERROR 2240 (AIR IN LINE/SET) ON THE HC DEVICE DURING DWELL 4 OF 5 OF PERITONEAL DIALYSIS (PD) THERAPY, WHILE THE PATIENT WAS CONNECTED. NOTHING WAS FOUND DURING TROUBLESHOOTING THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE ALARM. THE PATIENT THEN CLEARED THE ALARM. IT IS UNKNOWN HOW THE PATIENT PLANNED TO COMPLETE THERAPY. THERE WAS NO REPORT OF PATIENT INJURY, MEDICAL INTERVENTION, OR ADVERSE EVENT ASSOCIATED WITH THIS REPORT. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    602235 SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 HOMECHOICE PRO