BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    MDR report key: 4192524 · Received October 22, 2014

    Report

    Report Number
    1416980-2014-36896
    Event Type
    Malfunction
    Date Received
    October 22, 2014
    Date of Event
    September 28, 2014
    Report Date
    September 28, 2014
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    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 WAS UNKNOWN, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT RECEIVED A SYSTEM ERROR 2240 (AIR IN SET/LINE) DURING USE OF THE HOMECHOICE MACHINE. THIS EVENT OCCURRED DURING DWELL TWO OF TWO WHILE THE PATIENT WAS CONNECTED. THE TECHNICAL SERVICES REPRESENTATIVE ASSISTED THE PATIENT IN CLEARING THE ALARM. DURING TROUBLESHOOTING, NO ABNORMALITIES WERE NOTED THAT COULD CAUSE OR CONTRIBUTE TO THIS SYSTEM ERROR. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION IN ASSOCIATION WITH THIS REPORT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    671654 SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR HOMECHOICE