BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PD CYCLER 115V, HOMECHOICE

    MDR report key: 2981098 · Received February 27, 2013

    Report

    Report Number
    1416980-2013-04793
    Event Type
    Malfunction
    Date Received
    February 27, 2013
    Date of Event
    February 7, 2013
    Report Date
    February 7, 2013
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INITIAL EVALUATION CONFIRMED THE REPORTED CONDITION. UPON COMPLETION OF BAXTER'S INVESTIGATION, OR IF ADDITIONAL RELEVANT INFORMATION IS OBTAINED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTED ISSUE WAS CONFIRMED OVER THE PHONE. THE DEVICE PASSED BOTH THE HC RETURN INSTRUMENT TEST / EVALUATION (RITE) ELECTRICAL TEST AND THE RITE FUNCTIONAL TEST. REVIEW OF 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 IIPV-ADULT. THE ASSIGNABLE CAUSE WAS UNDETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A HIGH DRAIN 105 ALARM OCCURRED DURING THERAPY ON THE HOMECHOICE MACHINE(HC). THE HOME PATIENT(HP) STATED HE HAD NO PROBLEMS DURING THERAPY LAST NIGHT AND WANTED TO CONTINUE THERAPY. THE HC UNIT WAS OPERATIONAL. THERE WAS PATIENT INVOLVEMENT; HOWEVER, THERE WAS NO INJURY OR MEDICAL INTERVENTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    83435 PD CYCLER 115V, HOMECHOICE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR HOMECHOICE AUTOMATED PD SET WITH CASSETTE