BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 3171041 · Received June 14, 2013

    Report

    Report Number
    1416980-2013-15437
    Event Type
    Malfunction
    Date Received
    June 14, 2013
    Date of Event
    May 22, 2013
    Report Date
    May 22, 2013
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RECEIVED FOR EVALUATION. A REVIEW OF THE DEVICE LOGS DID NOT CONFIRM THE REPORTED ISSUE. THE DEVICE PASSED ELECTRICAL TESTING BUT FAILED FUNCTIONAL TESTING DUE TO EXCEEDING VOLUMETRIC LIMITS. EXTERNAL AND INTERNAL VISUAL INSPECTION DID NOT REVEAL ANY PROBLEMS. THE DEVICE PASSED TEMPERATURE VERIFICATION. TESTING FOUND NO LEAKS IN THE PNEUMATIC SYSTEM AND ALL PRESSURES WERE FOUND TO BE CORRECT AND STABLE. THE PROBLEM WAS CONFIRMED THROUGH EVALUATION. THE ASSIGNABLE CAUSE OF THE ISSUE WAS DETERMINED TO BE PISTON FOAM DISINTEGRATION. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE, A HOMECHOICE (HC) MACHINE WAS NOT FILLING WITH THE CORRECT AMOUNT OF FLUID. THE REGISTERED NURSE (RN) HAD TOLD THE HOME PATIENT (HP) TO CONTACT BAXTER. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ARRANGED TO SWAP THE HC AND DISCUSSED THE USE OF CONTINUOUS AMBULATORY PERITONEAL DIALYSIS UNTIL THE NEW MACHINE ARRIVES. THE HP WAS DIABETIC AND THE TSR ADVISED THE HP TO SPEAK WITH THE RN ABOUT THE MISSED THERAPY. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS INDICATED IN ASSOCIATION WITH THIS REPORT. NO ADDITIONAL INFORMATION IS AVAILABLE

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270517 HOMECHOICE PRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR