BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE

    MDR report key: 3024053 · Received March 27, 2013

    Report

    Report Number
    1416980-2013-07498
    Event Type
    Malfunction
    Date Received
    March 27, 2013
    Date of Event
    March 5, 2013
    Report Date
    March 5, 2013
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE CAUSE WAS UNDETERMINED. REVIEW OF THE SERVICE HISTORY REVEALED NO FAILURES/PROBLEMS THAT WERE THE SAME AS, OR SIMILAR TO, THE CURRENT DIFFICULTY AND THERE WAS NO INDICATION THAT THE PARTS REPLACED DURING SERVICING CAUSED OR CONTRIBUTED TO THE REPORTED DIFFICULTY. REVIEW OF THE DEVICE SERVICE HISTORY REVEALED NO ISSUES THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED DIFFICULTY OF AN IIPV - ADULT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN INCREASED INTRA-PERITONEAL VOLUME (IIPV) EVENT OCCURRED. THE CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER TO REPORT A HIGH DRAIN / CALL PD NURSE ALARM ON A HOMECHOICE (HC) DEVICE DURING DRAIN 1 OF 4. THE LAST DRAIN VOLUME WAS 3255ML, THE THERAPY STEP IN WHICH THE HP FELT IIPV SYMPTOMS WAS THE DWELL CYCLE, THE LAST VOLUME INFUSED WAS 1500 ML IN THE LAST FILL OF THE PREVIOUS THERAPY, AND THE LARGEST PRESCRIBED FILL VOLUME (LPFV) IS 1500 ML NIGHT FILL VOLUME. THE TSR ADVISED THE CALLER TO INFORM THE REGISTERED NURSE (RN) OF THE ALARM. THE CALLER DOES NOT WANT A SWAP. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS INDICATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125509 HOMECHOICE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR HOMECHOICE AUTOMATED PD SET WITH CASSETTE