BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2110746 · Received June 2, 2011

    Report

    Report Number
    1423500-2011-06935
    Event Type
    Malfunction
    Date Received
    June 2, 2011
    Date of Event
    May 8, 2011
    Report Date
    May 8, 2011
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SHOULD ANY FURTHER INFORMATION BECOME AVAILABLE, A FOLLOW UP WILL BE SENT.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR A CHECK YOUR POSITION ALARM WAS NOT CONFIRMED. THE ROOT CAUSE WAS "AIR IN PATIENT LINE." BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    Description of Event or Problem · 1

    A HOME PATIENT (HP) CONTACTED (B)(4) REGARDING A CHECK YOUR POSITION ALARM THAT OCCURRED ON THE HOMECHOICE (HC) MACHINE DURING FILL 1. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED ALARM AND ASSISTED THE HP WITH TROUBLESHOOTING. THE HP STATED THERE WERE A LOT OF AIR BUBBLES IN THE LINES. THE TSR INSTRUCTED THE HP TO END THERAPY AND START OVER WITH NEW SUPPLIES. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION.

    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 41 YR HOMECHOICE