BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE

    MDR report key: 3032634 · Received April 3, 2013

    Report

    Report Number
    1416980-2013-08216
    Event Type
    Malfunction
    Date Received
    April 3, 2013
    Date of Event
    March 12, 2013
    Report Date
    March 13, 2013
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PM
    Reporter Occupation
    PATIENT

    Narratives

    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 ANY ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HISTORY LOG REVIEW, EVENT HISTORY LOG REVIEW, AND SERVICE HISTORY REVIEW REVEALED NO ISSUES RELATED TO THE REPORTED PROBLEM. THE DEVICE WAS VISUALLY INSPECTED AND UNDERWENT FUNCITONAL TESTING WITH NO ISSUES NOTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT A HOMECHOICE DISPLAYED AN ALARM INDICATING THAT THE SOLUTION HAD BEEN OVERHEATED DURING PERITONEAL DIALYSIS. THERE WAS PATIENT INVOLVEMENT, BUT NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136725 HOMECHOICE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1