BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE CYCLER-REFURBISHED

    MDR report key: 1843347 · Received September 24, 2010

    Report

    Report Number
    1423500-2010-03679
    Event Type
    Malfunction
    Date Received
    September 24, 2010
    Date of Event
    August 25, 2010
    Report Date
    August 25, 2010
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K053512
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE RITE (RETURN INSTRUMENT TEST/EVALUATION) TEST WAS PERFORMED ON THE RETURNED HOMECHOICE (HC) DEVICE. THE DEVICE PASSED RITE ELECTRICAL TEST BUT FAILED RITE FUNCTIONAL TEST (B)(4) FOR VOLUMETRIC ACCURACY. REVIEW OF THE RITE FUNCTIONAL TEST RESULT REVEALED THE FOLLOWING: FILL 1: 822.6 ML; DRAIN 1: 822.3 ML. LIMITS: LOW 774.0 ML; HIGH 821.0 ML. THE EVENT LOG RECORDED THE THERAPY DATA FROM (B)(6) 2010 AND RECORDED NO DRAIN VOLUME AMOUNT EXCEEDS THE CURRENT INCREASED INTRA-PERITONEAL VOLUME (IIPV) CRITERIA. THE LOG RECORDED NO ULTRAFILTRATION VOLUME PER CYCLE THAT EXCEEDS THE CURRENT IIPV CRITERIA. THE CAUSE FOR THE FAILED FILL 1 / DRAIN 1 VOLUMETRIC ACCURACY WAS DETERMINED TO BE A CRACKED PISTON. RENAL QUALITY ENGINEERING, ALONG WITH PLANT MANUFACTURING AND QUALITY PERSONNEL, WILL CONTINUE TO MONITOR PRODUCT LINES FOR TRENDS AND WILL TAKE CORRECTIVE/PREVENTIVE ACTION AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RECEIVED, AND THE EVALUATION IS IN PROCESS. A FOLLOW-UP MEDWATCH WILL BE SUBMITTED UPON COMPLETION OF THE EVALUATION OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    DURING EVALUATION OF A RETURNED HOMECHOICE (HC) DEVICE FOR A SYSTEM ERROR 2197 THE PRODUCT ANALYSIS LABORATORY DETERMINED THE HC MACHINE SYSTEM FAILED RETURNED INSTRUMENT TEST/EVALUATION TESTING FOR FILL 1 / DRAIN 1 VOLUMETRIC ACCURACY. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR