BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    MDR report key: 3882484 · Received June 18, 2014

    Report

    Report Number
    1416980-2014-19437
    Event Type
    Malfunction
    Date Received
    June 18, 2014
    Date of Event
    May 24, 2014
    Report Date
    May 24, 2014
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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 NOT RETURNED AND THE LOT NUMBER IS UNKNOWN, A DEVICE ANALYSIS CANNOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). AS THE SAMPLE WAS NOT RETURNED, A COMPLETE DEVICE ANALYSIS CANNOT BE PERFORMED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A HOMECHOICE DEVICE EXPERIENCED A SYSTEM ERROR 2240 ALARM (AIR IN LINE/SET). THIS EVENT OCCURRED DURING THE LAST DRAIN CYCLE OF PERITONEAL DIALYSIS THERAPY WHILE THE PATIENT WAS CONNECTED. THE PATIENT HAD IMPROPERLY DISCONNECTED FROM THE HOMECHOICE AND HAD RECONNECTED BEFORE THE ALARM OCCURRED. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED THE ALARM AND PROPER DISCONNECT PROCEDURES. THE PATIENT WAS TO COMPLETE THERAPY USING NEW SUPPLIES. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    357239 SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 HOMECHOICE