BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2122314 · Received June 13, 2011

    Report

    Report Number
    1423500-2011-07539
    Event Type
    Malfunction
    Date Received
    June 13, 2011
    Date of Event
    January 27, 2011
    Report Date
    May 19, 2011
    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). IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THEN A FOLLOW UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). A SYSTEM ERROR 2240 ALARM WAS IDENTIFIED IN THE LOG OF A RETURNED HOMECHOICE DEVICE. THIS COMPLAINT WAS CONFIRMED BECAUSE, THE ALARM WAS IDENTIFIED IN THE EVENT LOG OF THE HOMECHOICE DEVICE USED IN CONJUNCTION WITH THE DISPOSABLE CASSETTE. THE CAUSE CANNOT BE DETERMINED BASED ON THE INFORMATION IN THE COMPLAINT; THE DISPOSABLE WAS NOT RETURNED FOR EVALUATION, THE LOT NUMBER WAS UNKNOWN, AND NO USE ERROR THAT MAY HAVE CAUSED THE ALARM WAS REPORTED. INVESTIGATION NUMBER (B)(4) IS OPEN TO ADDRESS SYSTEM ERROR 2240 ALARMS.

    Description of Event or Problem · 1

    A SYSTEM ERROR (SE) 2240 ALARM WAS IDENTIFIED IN THE LOG OF A RETURNED HOMECHOICE DEVICE. THE SYSTEM ERROR OCCURRED DURING DRAIN 1 OF CYCLE 4. A SE 2240 IS A NON-RECOVERABLE ALARM THAT OCCURS WHEN THE DEVICE HAS DETECTED AIR BEING DRAWN CONTINUOUSLY INTO THE DISPOSABLE. IT IS UNKNOWN IF THIS ALARM OCCURRED DURING PATIENT THERAPY; HOWEVER, NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED. THERE WAS NO REPORT FOR THIS ALARM CALLED IN BY THE CUSTOMER. NO ADDITIONAL 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 70 YR