BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE

    MDR report key: 2950278 · Received February 8, 2013

    Report

    Report Number
    1416980-2013-03257
    Event Type
    Malfunction
    Date Received
    February 8, 2013
    Date of Event
    January 24, 2013
    Report Date
    January 24, 2013
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    SERVICE AND TESTING PERSONNEL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED AND EVALUATED BY THE PRODUCT ANALYSIS LAB (PAL). THE PAL EVALUATED THE DEVICE FOR THE ISSUE OF FAILED HOMECHOICE (HC) RETURN INSTRUMENT TEST/EVALUATION (RITE) FAILED FUNCTIONAL TEST FOR THERAPY MONITORED VOLUME FAILED PERFORMANCE SPECIFICATION. ACCURACY TEST FAILED WITH ORIGINAL PISTON FOAM; HOWEVER PASSED WITH TEST ARTICLE PISTON FOAM. TEMPERATURE CONFIRMATION TEST PASSED. INSPECTION OF THE DOOR ASSEMBLY REVEALED DETERIORATED DOOR PISTON FOAM. THE ASSIGNABLE CAUSE FOR THE REPORTED RITE ISSUE WAS DETERMINED TO BE INSUFFICIENT DOOR PISTON FOAM. SCRAP DOOR PISTON FOAM. DEVICE WILL BE SENT TO SERVICING.

    Description of Event or Problem · 1

    THE CUSTOMER DISCONTINUED USE OF THE HOMECHOICE (HC) MACHINE AND RETURNED IT TO BAXTER (B)(4). THE PRODUCT ANALYSIS LABORATORY (PAL) DETERMINED THE HC MACHINE SYSTEM FAILED RITE (RETURNED INSTRUMENT TEST/EVALUATION) TESTING DUE TO A RITE - THERAPY MONITORED VOLUME FAILED PERFORMANCE SPEC. NO PATIENT INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    53786 HOMECHOICE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1