BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE

    MDR report key: 3517198 · Received December 12, 2013

    Report

    Report Number
    1416980-2013-34385
    Event Type
    Malfunction
    Date Received
    December 12, 2013
    Date of Event
    November 20, 2013
    Report Date
    November 20, 2013
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS REPORTED TO BE AVAILABLE BUT HAS NOT YET BEEN RECEIVED. A TREND REVIEW WILL BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE HOMECHOICE (HC) DEVICE WAS RETURNED FOR EVALUATION. A DEVICE HISTORY RECORD REVIEW AND A SERVICE HISTORY RECORD REVIEW WERE PERFORMED AND REVEALED NO ISSUES THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED CONDITION. A REVIEW OF THE EVENT HISTORY LOG OF THE DEVICE COULD NOT CONFIRM THE REPORTED EVENT. ALL ELECTRONIC COMPONENTS THAT CONTROL THE TEMPERATURE WERE CHECKED AND FOUND TO BE IN GOOD WORKING CONDITION. FUNCTIONAL TESTING, INCLUDING TEMPERATURE AND CALIBRATION TESTING, FOUND NO ISSUES. THE REPORTED PROBLEM WAS NOT CONFIRMED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HOMECHOICE (HC) WAS HEATING THE SOLUTION MORE THAN USUAL DURING USE. A SWAP OF THE HC WAS ARRANGED. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS INDICATED AS A RESULT OF THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    651971 HOMECHOICE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1