BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2073049 · Received April 29, 2011

    Report

    Report Number
    1423500-2011-05210
    Event Type
    Malfunction
    Date Received
    April 29, 2011
    Date of Event
    November 29, 2010
    Report Date
    November 29, 2010
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT FOR A SYSTEM ERROR 2240 (AIR IN LINE) ALARM WAS NOT CONFIRMED IN THE LAB DUE TO A LACK OF SAMPLE; HOWEVER, FROM THE COMPLAINT INFORMATION, THE CAUSE OF THE ALARM WAS A LOOSE CONNECTION BETWEEN THE PATIENT LINE AND TRANSFER SET. THE LOT NUMBER IS UNKNOWN THEREFORE A BATCH REVIEW WAS NOT PERFORMED. THE LABELING REVIEW FOUND THE LABELING ADEQUATE FOR THE USE ERROR IDENTIFIED IN THIS COMPLAINT. SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S (B)(4) AND REPORTED A SYSTEM ERROR (S/E) 2240 ALARM THAT APPEARED ON THE HOME CHOICE (HC) DURING THE INITIAL DRAIN; THE PATIENT WAS NOT CONNECTED AT THE TIME OF THE ALARM. THE HOME PATIENT (HP) BECAME DISCONNECTED DURING DWELL. THE PATIENT WAS WOKEN BY THE ALARM AND NOTICED HE WAS DISCONNECTED IN THE DWELL CYCLE. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ADVISED THE HP TO END THERAPY AND EITHER START OVER WITH NEW DISPOSABLES OR PERFORM THERAPY MANUALLY. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 HOMECHOICE