BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 3902359 · Received June 30, 2014

    Report

    Report Number
    1416980-2014-20830
    Event Type
    Malfunction
    Date Received
    June 30, 2014
    Report Date
    May 21, 2014
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE EVALUATION WAS COMPLETED. THE REPORTED EVENT OF ¿CONTINUOUS BEEPING¿ FROM THE HOMECHOICE (HC) DEVICE WAS VERIFIED AS A DISPLAY ISSUE DURING THE SAMPLE EVALUATION. THE CAUSE WAS DETERMINED TO BE A DIGITAL PRINTED CIRCUIT BOARD (PCB) WHICH WAS SCRAPPED. IF ANY ADDITIONAL RELEVANT INFORMATION IS OBTAINED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION AND FUNCTIONAL TESTING WERE PERFORMED. DURING FUNCTIONAL TESTING, THE DEVICE DID NOT START UP PROPERLY AND THE ISSUE WAS VERIFIED. THE CAUSE OF THE CONDITION WAS DETERMINED TO BE DUE TO A DIGITAL BOARD ISSUE. THE EVENT HISTORY LOG COULD NOT BE DOWNLOADED DUE TO THE ISSUE WITH THE DIGITAL BOARD. THE DIGITAL BOARD WAS REPLACED TO RESOLVE THE ISSUE. AFTER REPLACING THE BOARD, THE DEVICE WAS ABLE TO PASS A SIMULATED THERAPY TEST, FULL FUNCTIONAL TESTING, ELECTRICAL TESTING, AND CALIBRATION. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A HOMECHOICE PRO WAS "CONTINUOUSLY BLEEPING". THE SPECIFIC ALARM WAS NOT REPORTED. IT WAS NOT SPECIFIED WHEN IN THE THERAPY THIS OCCURRED. IT IS UNKNOWN IF THERE WAS PATIENT INVOLVEMENT; HOWEVER, THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    379731 HOMECHOICE PRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1