BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3971198 · Received July 31, 2014

    Report

    Report Number
    1416980-2014-24841
    Event Type
    Malfunction
    Date Received
    July 31, 2014
    Date of Event
    July 7, 2014
    Report Date
    July 8, 2014
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). UPON COMPLETION OF BAXTER'S INVESTIGATION, IF ADDITIONAL RELEVANT INFORMATION IS OBTAINED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). AN ALARM INDICATIVE OF A POTENTIAL MALFUNCTION OF THE DISPOSABLE CASSETTE WAS IDENTIFIED. THE DEVICE WAS NOT RETURNED FOR ANALYSIS; THEREFORE, NO EVALUATION COULD BE PERFORMED. HOWEVER, IT WAS REPORTED THAT A SOLUTION BAG DISCONNECTED FROM THE SETUP (WITHOUT FALLING) WHICH IS KNOWN TO CAUSE THIS ALARM. IF ADDITIONAL RELEVANT INFORMATION IS OBTAINED, THEN A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SYSTEM ERROR 2240 (AIR IN SET/LINE) ALARM OCCURRED ON THE HOMECHOICE (HC) DEVICE DURING FILL 2 OF 4. THE HOME PATIENT (HP) WAS CONNECTED AT THE TIME OF THE ALARM. DURING TROUBLESHOOTING, IT WAS NOTED THAT THE HEATER BAG DISCONNECTED FROM THE HEATER LINE WITHOUT FALLING. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED THE ALARM TO THE HP AND ASSISTED THE HP IN CLEARING THE ALARM. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE REPORT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    446493 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR HOMECHOICE