BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 3033519 · Received April 3, 2013

    Report

    Report Number
    1416980-2013-08278
    Event Type
    Malfunction
    Date Received
    April 3, 2013
    Date of Event
    March 1, 2013
    Report Date
    March 12, 2013
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A REVIEW OF THE DEVICE HISTORY AND SERVICE HISTORY DID NOT REVEAL ANYTHING RELATED TO THE REPORTED ISSUE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). ACTUAL DATE OF THE EVENT IS UNKNOWN. THE HOMECHOICE (HC) DEVICE WAS RETURNED AND WAS EVALUATED BY THE PRODUCT ANALYSIS LAB (PAL) FOR THE REPORTED ISSUE OF OVERHEATING. A REVIEW OF THE DEVICE LOGS REVEALED NO FAILURE OR MALFUNCTION THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED DIFFICULTY. VISUAL INSPECTION OF DEVICE DIDN'T SHOW ANY ISSUES. THE DEVICE WAS TESTED UNDER TEMPERATURE MONITORING SYSTEM SOFTWARE, AND THE PROBLEM WAS NEITHER CONFIRMED NOR REPRODUCED. ALL PRODUCT SPECIFICATIONS WERE MET. THE PROBLEM WAS NOT CONFIRMED. THE CAUSE OF THE PROBLEM WAS UNDETERMINED. THE DEVICE WAS SENT FOR SERVICING. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). A REQUEST FOR THE RETURN OF THE DEVICE HAS BEEN MADE. SHOULD THE DEVICE BE RECEIVED BY BAXTER FOR EVALUATION, A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF AN EVALUATION OR IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    A CUSTOMER ALLEGED THAT HIS HOMECHOICE HAD OVERHEATED "MORE THAN ONCE" ON UNKNOWN DATES. THERE WAS PATIENT INVOLVEMENT, BUT NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135795 HOMECHOICE PRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1