BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE

    MDR report key: 4101593 · Received September 19, 2014

    Report

    Report Number
    1416980-2014-32192
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Date of Event
    August 25, 2014
    Report Date
    August 25, 2014
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE HOMECHOICE (HC) DEVICE EVALUATION WAS COMPLETED. A REVIEW OF THE SERVICE HISTORY REVEALED NO FAILURES OR PROBLEMS THAT WERE THE SAME AS, OR SIMILAR TO THE REPORTED CONDITION, AND THERE WAS NO INDICATION THAT THE PARTS REPLACED DURING SERVICING CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE DEVICE UNDERWENT AN EXTERNAL/INTERNAL INSPECTION WHICH FOUND NO ISSUES. THE HC MACHINE WAS ALSO PUT THROUGH AND PASSED THE FUNCTIONAL AND ELECTRICAL RETURN INSTRUMENT TESTING EVALUATION (RITE). A SHORT SIMULATED THERAPY WAS PERFORMED WITHOUT ISSUES. THE DEVICE'S PNEUMATIC SYSTEM WAS TESTED AND PASSED. THERE WAS NO NON-CONFORMING PRODUCT IDENTIFIED DURING THE SAMPLE EVALUATION. THE EVENT HISTORY LOG WAS REVIEWED AND VERIFIED THE REPORTED EVENT. THE LOG IDENTIFIED THAT THE LAST FILL VOLUME WAS 0 ML WHILE IT SHOULD BE 2000ML, AND THE TOTAL FILL VOLUME WAS 12 ML WHILE IT SHOULD BE 8400 ML. THE CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED. IF ADDITIONAL RELEVANT INFORMATION IS OBTAINED, THEN A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE HOMECHOICE (HC) WAS RETURNED AND IS CURRENTLY IN THE PROCESS OF BEING EVALUATED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE READINGS ON THE HOMECHOICE DEVICE WERE NOT CORRECT AFTER THERAPY. THE NURSE STATED THAT THE TOTAL ULTRA FILTRATION (UF) WAS 370ML AND THERE WERE CYCLE 1 AND CYCLE 2 UF VOLUMES, BUT NO CYCLE 2 UF WAS AVAILABLE. THE NURSE WAS CONCERNED THAT THE CALCULATIONS WERE NOT WORKING CORRECTLY. THE PATIENT TOLD THE NURSE THAT THEY WATCHED CYCLE 1 AND 3, BUT SLEPT THROUGH CYCLE 2. AFTER REVIEWING THE FILL VOLUME AND THE WEIGHT OF THE DRAIN BAG, THEY WERE UNABLE TO ACCOUNT FOR 1 LITER OF THE SOLUTION. THE TECHNICAL SERVICE REPRESENTATIVE EXPLAINED THAT THE LAST FILL WAS NOT INCLUDED IN THE DRAIN BAG AND THE PRIME FLUID, INITIAL DRAIN FLUID ALONG WITH ANY OTHER FLUID USED BY THE MACHINE DURING THERAPY WAS ALSO IN THE DRAIN BAG. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE REPORT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    585068 HOMECHOICE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR AUTOMATED PD SET WITH CASSETTE