BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 2993359 · Received March 7, 2013

    Report

    Report Number
    1416980-2013-05552
    Event Type
    Malfunction
    Date Received
    March 7, 2013
    Date of Event
    February 13, 2013
    Report Date
    February 19, 2013
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR A REPORT OF IIPV - ADULT WAS CONFIRMED. THE ROOT CAUSE WAS UNDETERMINED. THE HOMECHOICE WAS VISUALLY AND FUNCTIONALLY EVALUATED. THE ALARM WAS CONFIRMED IN THE EVENT LOG HISTORY REVIEW. THERE WERE NOT ANY KEYSTROKES, PROGRAMMING, OR USE RELATED EVENTS IN THE LOG THAT WOULD INDICATE OR CONTRIBUTE TO THE PROBLEM.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER'S SERVICE CENTER REGARDING A HIGH DRAIN 107 ALARM WHICH OCCURRED ON THE HOMECHOICE (HC) AFTER USE. THE HOME PATIENT (HP) STATED THAT WHEN HE SHUTS DOWN THE MACHINE, THE HC ALARMED REGARDING A DRAIN. THE BAXTER TECHNICAL SERVICES REPRESENTATIVE (TSR) REVIEWED THE ALARM LOG AND FOUND A HIGH DRAIN 107 ALARM. THE HP STATED THAT HE WAS USING 1.5% DIANEAL BAGS ON THE DAY THE ALARM OCCURRED. HE CALLED HIS REGISTERED NURSE (RN) WHO DID NOT KNOW WHAT THE ALARM MEANT, AND THE RN ADVISED HIM TO CALL BAXTER. HE WOULD EXPLAIN WHAT THE ALARM MEANT TO HIS RN. THE TSR REVIEWED THE TOTAL ULTRAFILTRATION, WHICH WAS EQUAL TO 1774ML, CYCLE 7 WAS SET TO 1979ML, AND CYCLE 6 -1 WAS 128ML. THE HP UNDERSTOOD WHY THE ALARM OCCURRED AND WOULD SWAP THE MACHINE. THE HP WOULD CALL FOR PROGRAMMING. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    97272 HOMECHOICE PRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1