BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE

    MDR report key: 3915053 · Received July 6, 2014

    Report

    Report Number
    1416980-2014-21622
    Event Type
    Malfunction
    Date Received
    July 6, 2014
    Date of Event
    June 6, 2014
    Report Date
    June 6, 2014
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RECEIVED AND THE EVALUATION IS IN PROGRESS. UPON COMPLETION OF THE INVESTIGATION, OR IF ANY ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). A REVIEW OF THE DEVICE HISTORY RECORDS REVEALED SEVERAL ALARMS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED DIFFICULTY. EXTERNAL AND INTERNAL INSPECTION WAS PERFORMED ON THE DEVICE AND MEET SPECIFICATIONS. THE DEVICE FAILED THE RETURN INSTRUMENT TEST/EVALUATION (RITE) FUNCTIONAL TEST AND DOWNLOAD. THE REPORTED AUDIBLE ALARM WAS VERIFIED; THE POWER WAS CYCLED ON THE UNIT SEVERAL TIMES, THERE WAS NO DISPLAY HOWEVER THE UNIT BEEPED WHEN BUTTONS WERE PRESSED. THE DIGITAL PCB WAS CHECKED AND ITS CONNECTIONS AND THE UNIT POWERED UP NORMALLY WHEN U26 WAS AGITATED. THE POOR CONNECTION CAUSED THE INTERMITTENT DIGITAL PCB MALFUNCTIONS RELATED TO SOFTWARE AND DISPLAY ISSUES. THE DEVICE WILL BE SENT FOR SERVICE AND THE U26 WILL BE REWORKED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A HOMECHOICE HAD AN AUDIBLE ALARM. THE SPECIFIC ALARM WAS NOT REPORTED. THE PATIENT WAS CONNECTED AT THE TIME OF THE ALARM. THE TECHNICAL SERVICE REPRESENTATIVE ASSISTED THE PATIENT IN ENDING THERAPY, ARRANGED A SWAP OF THE DEVICE, AND DISCUSSED THE USE OF CONTINUOUS AMBULATORY PERITONEAL DIALYSIS (CAPD) UNTIL THE NEW DEVICE ARRIVED. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    393075 HOMECHOICE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR HOMECHOICE