BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3251604 · Received July 29, 2013

    Report

    Report Number
    1416980-2013-19998
    Event Type
    Malfunction
    Date Received
    July 29, 2013
    Date of Event
    July 7, 2013
    Report Date
    July 22, 2013
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING EVALUATION OF A HOMECHOICE HARDWARE DEVICE AN ALARM INDICATIVE OF A POTENTIAL MALFUNCTION OF THE DISPOSABLE CASSETTE WAS IDENTIFIED. AS THE CASSETTE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN, A DEVICE ANALYSIS CANNOT BE COMPLETED. AS A RESULT, THE CAUSE OF THE REPORTED ISSUE CANNOT BE DETERMINED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    DURING EVALUATION OF A RETURNED HOMECHOICE DEVICE, A SYSTEM ERROR 2240 ALARM (AIR IN SET) WAS IDENTIFIED IN THE LOG WHICH INDICATES A POTENTIAL MALFUNCTION OF THE DISPOSABLE CASSETTE. THE ALARM OCCURRED ON (B)(6) 2013 04:04:10. NO FURTHER INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353635 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 HOMECHOICE