BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE

    MDR report key: 2760787 · Received September 26, 2012

    Report

    Report Number
    1416980-2012-00739
    Event Type
    Malfunction
    Date Received
    September 26, 2012
    Date of Event
    July 4, 2012
    Report Date
    September 3, 2012
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    SERVICE AND TESTING PERSONNEL

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT NO: (B)(4). (B)(6). EVALUATION: THE DEVICE WAS RETURNED TO BAXTER, AND THE EVALUATION IS COMPLETE. THIS COMPLAINT IS AN ANCILLARY SERVICE EVENT OPENED DURING INVESTIGATION OF (B)(4). THE CAUSE FOR THE IIPV WAS UNDETERMINED AS THERE WAS A LACK OF EVIDENCE TO MAKE A DETERMINATION. NO FURTHER ACTION IS REQUIRED AT THIS TIME. THE DEVICE WAS SERVICED ACCORDING TO REQUIRED PROCEDURES AND THE DEVICE PASSED ALL TESTS AS PER BAXTER PROCEDURES. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP WILL BE SENT.

    Description of Event or Problem · 1

    A HIGH DRAIN ERROR 101 (NIGHT DRAIN CYCLE ONE) ALARM WAS IDENTIFIED IN THE LOG OF A RETURNED HOMECHOICE DEVICE. THE ALARM OCCURRED ON (B)(6) 2012 06:04:22. THIS INFORMATION MEETS IIPV CRITERIA. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1