BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 3243645 · Received July 23, 2013

    Report

    Report Number
    1416980-2013-19511
    Event Type
    Malfunction
    Date Received
    July 23, 2013
    Date of Event
    June 27, 2013
    Report Date
    June 28, 2013
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RECEIVED FOR EVALUATION. IT WENT THROUGH VISUAL INSPECTION AND FUNCTIONAL TESTINGS. DURING VISUAL INSPECTION, THE POWER INLET MODULE WAS FOUND TO BE BURNT. THE REPORTED CONDITION WAS CONFIRMED AND DUPLICATED. THE POWER CORD, POWER INLET MODULE AND 5A FUSES WERE REPLACED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE CAUSE OF THE REPORTED ISSUE WAS DETERMINED TO BE A BURNT POWER INLET MODULE AND BURNT FUSES. THE DEVICE WAS SERVICED AND RETURNED TO GOOD WORKING CONDITION. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A HOMECHOICE'S POWER CORD HAD SIZZLING NOISES, WHICH OCCURRED WHEN THE DEVICE WAS TURNED ON. THE PATIENT WAS NOT CONNECTED. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342920 HOMECHOICE PRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1