BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 2983323 · Received February 28, 2013

    Report

    Report Number
    1416980-2013-04943
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Date of Event
    February 12, 2013
    Report Date
    February 12, 2013
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PATIENT

    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 RITE - THERAPY MONITORED VOLUME FAILED PERFORMANCE SPECIFICATION. AN ACCURACY CONFIRMATION TEST WAS PERFORMED, AND DEVICE FAILED TO MEET VOLUMETRIC ACCURACY SPECIFICATION. TEMPERATURE VERIFICATION TEST WAS PERFORMED, AND DEVICE PASSED ALL TESTS. THE CYCLER REMOTE TOOLBOX (CRT) SOFTWARE WAS USED TO DIAGNOSE THE DEVICE PNEUMATIC SYSTEM. CRT TEST REVEALED NO LEAKS, AND ALL PRESSURES WERE CORRECT AND STABLE. AN EXTERNAL/INTERNAL INSPECTION WAS PERFORMED, AND NO PROBLEMS WERE REVEALED. PAL PERFORMED A MORE DETAILED INSPECTION OF DOOR ASSEMBLY. INSPECTION REVEALED THAT PISTON FOAM IS DETERIORATED, WHICH IS THE ASSIGNABLE CAUSE OF THE REPORTED RITE FAILURE. DEVICE DID NOT MEET SPECIFICATION FOR THE REPORTED PROBLEM. PAL HAS IDENTIFIED PISTON FOAM TO BE SCRAPPED. CORRECTION TO THE DEVICE WILL BE PERFORMED DURING SERVICE.

    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: FILL 1 830.4 ML, DRAIN 1 830.6 ML, FILL 2 830.2 ML, DRAIN 2 830.3 ML. THESE VOLUMES ARE OUTSIDE THE RANGE OF 750.0 ML - 828.2 ML, THEREFORE, THIS IS A REPORTABLE MALFUNCTION. RITE TEST FAILURE, NO PATIENT INVOLVED. AFTER REVIEW OF THE (B)(4) SYSTEM, THE CUSTOMER DISCONTINUED USE OF THE DEVICE DUE TO: DROP OUT. THIS MALFUNCTION WAS FOUND BY A BAXTER TECHNICIAN DURING SERVICE OF A DEVICE THAT WAS RETURNED AS A DROP OUT AND WAS NOT REPORTED BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    86869 HOMECHOICE PRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1