BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 3954158 · Received July 23, 2014

    Report

    Report Number
    1416980-2014-23954
    Event Type
    Malfunction
    Date Received
    July 23, 2014
    Date of Event
    June 30, 2014
    Report Date
    June 30, 2014
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE HOMECHOICE (HC) DEVICE WAS RETURNED AND EVALUATED BY THE PRODUCT ANALYSIS LAB (PAL). THE EVENT HISTORY LOG REVIEW SHOWED NO KEYSTROKES, PROGRAMMING, OR USE RELATED EVENTS THAT INDICATED AND/OR CONTRIBUTED TO THE RITE (RETURNED INSTRUMENT TEST EVALUATION) FAILURE. THE EXTERNAL/INTERNAL INSPECTION WAS PERFORMED AND THE DEVICE PASSED, ALONG WITH ALL OF THE ELECTRICAL TESTING. DURING THE EVALUATION, THE FLUID WAS TRANSFERRED ABOVE THE RITE SPECIFIED LIMITS AND THE VOLUMETRIC ACCURACY TEST THAT FOLLOWED, SHOWED THAT THE DEVICE HAD FAILED. PAL PERFORMED A MORE DETAILED INSPECTION OF THE DOOR ASSEMBLY. THE INSPECTION SHOWED THAT THE PISTON FOAM WAS DETERIORATED AND THE DOOR PISTON WAS CRACKED. THE EVALUATION CONCLUDED THAT THE CAUSE OF THE FAILED FLUID VOLUME ACCURACY TESTING WAS A COMBINATION OF THE DETERIORATED PISTON FOAM AND A CRACKED DOOR PISTON. THE PISTON FOAM AND THE DOOR PISTON WERE REPLACED TO RESOLVE THE ISSUE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    DURING EVALUATION OF A RETURNED HOMECHOICE (HC) DEVICE, A BAXTER TECHNICIAN DETERMINED THE HC MACHINE FAILED RITE (RETURNED INSTRUMENT TEST/EVALUATION) TESTING FOR FLUID VOLUME ACCURACY. DEVICE FAILED DURING EVALUATION, NO PATIENT INVOLVED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    430318 HOMECHOICE PRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1