BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 2031929 · Received March 28, 2011

    Report

    Report Number
    1423500-2011-03745
    Event Type
    Malfunction
    Date Received
    March 28, 2011
    Date of Event
    March 3, 2011
    Report Date
    March 3, 2011
    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). THE DEVICE HAS BEEN RECEIVED BY BAXTER FOR EVALUATION; HOWEVER, THE EVALUATION IS NOT COMPLETE AT THIS TIME. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF BAXTER'S INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER DISCONTINUED USE OF THE HOMECHOICE DEVICE FOR AUTOMATED PERITONEAL DIALYSIS THERAPY AND RETURNED IT TO THE (B)(4) FACILITY. RITE (RETURN INSTRUMENT TEST/EVALUATION) TEST WAS PERFORMED BY THE PRODUCT ANALYSIS LAB (PAL). THE DEVICE FAILED RITE FUNCTIONAL TEST BUT PASSED RITE ELECTRICAL TEST. THE REPORTED DIFFICULTY OF FAILED VOLUMETRIC ACCURACY DURING FILL 1, DRAIN 1, FILL 2, AND DRAIN 2 WAS CONFIRMED BY REVIEWING THE RITE FUNCTIONAL TEST REPORT DURING PAL EVALUATION. THE ASSIGNABLE CAUSE OF THE RITE FAILURE OF FAILED FILL 1, DRAIN 1, FILL 2, AND DRAIN 2 VOLUMETRIC ACCURACY WAS DETERMINED TO BE DETERIORATED PISTON FOAM. AS A RESULT OF THIS INCIDENT, THE PISTON AND PISTON FOAM WILL BE REPLACED DURING SERVICING OF THE DEVICE. RENAL QUALITY ENGINEERING WILL CONTINUE TO TRACK AND TREND THESE COMPLAINT REPORTS AND TAKE CORRECTIVE AND PREVENTIVE ACTION AS APPROPRIATE.

    Description of Event or Problem · 1

    DURING EVALUATION OF A HOMECHOICE (HC), THE PRODUCT ANALYSIS LABORATORY (PAL) DETERMINED THE HC FAILED THE RETURNED INSTRUMENT TEST/EVALUATION (RITE) DUE TO A THERAPY MONITORED VOLUME FAILING PERFORMANCE SPECIFICATIONS. NO ALLEGATIONS WERE MADE AGAINST ANY OF THE PATIENT?S DIALYSIS PRODUCTS. NO INJURY OR MEDICAL INTERVENTION WAS INDICATED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR