BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3123001 · Received May 21, 2013

    Report

    Report Number
    1416980-2013-13094
    Event Type
    Malfunction
    Date Received
    May 21, 2013
    Date of Event
    May 1, 2013
    Report Date
    May 1, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INITIAL EVALUATION CONFIRMED THE REPORTED CONDITION. THE ASSIGNABLE CAUSE OF THE REPORTED ISSUE WAS DETERMINED TO BE THE SUPPLY BAG FELL AND DISCONNECTED SINCE IT HAS THE POSSIBILITY OF INTRODUCING AIR INTO THE SYSTEM AND, IN TURN, CAUSE THE ALARM. INITIAL EVALUATION CONFIRMED THE REPORTED CONDITION. 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 OCCURRED ON THE HOMECHOICE (HC) DURING DWELL 3 OF 4 WHILE THE HOME PATIENT (HP) WAS CONNECTED. THE HP STATED THAT THE SUPPLY BAG FELL AND DISCONNECTED ALLOWING AIR TO ENTER THE SETUP AND, IN TURN, CAUSING THE ALARM. THE HP CYCLED THE POWER IN ORDER TO CLEAR THE ALARM. HOWEVER, THE HC ALARMED WITH SYSTEM ERROR 2367. THE HP CYCLED THE POWER AGAIN IN ORDER TO CLEAR SYSTEM ERROR 2367 AND END THE CURRENT THERAPY. THE HP WAS GOING TO DO A MANUAL EXCHANGE. THERE WAS PATIENT INVOLVEMENT, BUT 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
    224558 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 HOMECHOICE