BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 2871450 · Received December 13, 2012

    Report

    Report Number
    1416980-2012-07191
    Event Type
    Malfunction
    Date Received
    December 13, 2012
    Date of Event
    November 28, 2012
    Report Date
    November 28, 2012
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE IS NOT AVAILABLE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE PROBLEM WAS CONFIRMED FOR USE ERROR-FAILED TO FOLLOW THERAPY STEPS ON THE PHONE. THE ASSIGNABLE CAUSE OF THE PROBLEM IS THE PATIENT INAPPROPRIATELY BYPASSED THE DRAIN PHASES WHICH IS A USE ERROR. 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 USE ERROR-FAILED TO FOLLOW THERAPY STEPS.

    Description of Event or Problem · 1

    THE HOME PATIENT (HP) CONTACTED BAXTER'S SERVICE CENTER REPORTING AN ALARM THAT OCCURRED ON THE HOMECHOICE (HC) DURING USE IN DRAIN 4 OF 4 AND THE HP STATED SHE BYPASSED EVERY DRAIN. THE TSR HAD THE HP CHECK FOR KINKS, CLOSED CLAMPS AND FIBRIN. THERE WERE NO PROBLEMS FOUND. THE HP REPOSITIONED AND THE ALARM REOCCURRED. THE TSR REVIEWED THE PROGRAM FOR CONTINUOUS CYCLING PERITONEAL DIALYSIS (CCPD). THE HP REQUESTED TO BYPASS AND THE TSR ASSISTED AS REQUESTED. THE TSR ASSISTED TO END THERAPY. THE HP HAD AN APPOINTMENT WITH THE REGISTERED NURSE (RN) AND TSR ADVISED THE HP TO LET THE RN KNOW OF THE ALARM. THERE WAS PATIENT INVOLVEMENT. THERE WAS NO SERIOUS INJURY OR MEDICAL INTERVENTION REPORTED.

    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 63 YR CASSETTE