BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 4192296 · Received October 22, 2014

    Report

    Report Number
    1416980-2014-36882
    Event Type
    Malfunction
    Date Received
    October 22, 2014
    Date of Event
    September 26, 2014
    Report Date
    September 26, 2014
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A REVIEW OF THE DEVICE LOGS DID NOT VERIFY THE FAILURE DURING THE VOLUMETRIC ACCURACY TEST. AN INTERNAL AND EXTERNAL INSPECTION WAS PERFORMED AND PASSED. A MANUAL VOLUMETRIC ACCURACY TEST WAS COMPLETED AND FAILED WITH THE ORIGINAL DOOR PISTON FOAM; HOWEVER, WHEN THE DOOR PISTON FOAM WAS REPLACED WITH A TEST ARTICLE, THE VOLUMETRIC ACCURACY TEST PASSED. A CHECK OF THE DOOR ASSEMBLY FOUND THE DOOR PISTON FOAM DETERIORATED AND THE DOOR PISTON CRACKED AT THE TOP OF THE PISTON. A MANUAL TEMPERATURE TEST WAS COMPLETED AND PASSED. THE RETURN INSTRUMENT TEST/EVALUATION (RITE) ELECTRICAL TEST PASSED. A REVIEW OF THE SERVICE DATA FOR REVEALED THERE IS NO PREVIOUS SERVICE HISTORY FOR THIS DEVICE. A REVIEW OF THE DEVICE HISTORY REVEALED NO NONCONFORMITIES, FAILURES, REWORK OR DEVIATIONS THAT WOULD CAUSE OR CONTRIBUTE TO THE REPORTED PROBLEM. THE CAUSE FOR THE RITE FUNCTIONAL TEST FAILURE FOR VOLUMETRIC ACCURACY WAS DETERMINED TO BE CAUSED BY DETERIORATED DOOR PISTON FOAM AND CRACKED DOOR PISTON. THE PISTON FOAM AND DOOR PISTON WAS SCRAPPED TO SOLVE THE PROBLEM. THE DEVICE WAS SENT FOR SERVICING. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    COMPLAINT NO: CMPLNT-(B)(4). THE DEVICE EVALUATION IS IN PROGRESS, BUT HAS NOT YET BEEN COMPLETED. UPON COMPLETION OF THE EVALUATION, OR 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 BAXTER TECHNICIAN DETERMINED THE HOMECHOICE DEVICE FAILED FLUID VOLUME ACCURACY TESTING. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    673864 HOMECHOICE PRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1