BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 3952495 · Received July 23, 2014

    Report

    Report Number
    1416980-2014-23832
    Event Type
    Malfunction
    Date Received
    July 23, 2014
    Date of Event
    June 29, 2014
    Report Date
    June 29, 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). AS THE DEVICE WAS NOT RETURNED, A COMPLETE DEVICE ANALYSIS COULD NOT BE PERFORMED. A SERVICE HISTORY REVIEW SHOWED NO FAILURES/PROBLEMS THAT WERE THE SAME AS, OR SIMILAR TO, THE CURRENT DIFFICULTY. IN ADDITION, THERE WAS NO INDICATION THAT PARTS REPLACED DURING SERVICING COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED DIFFICULTY. A REVIEW OF THE DEVICE HISTORY RECORDS REVEALED NO FAILURES OR MALFUNCTIONS RELATED TO THE REPORTED ALARM. UPON CONCLUSION OF THE INVESTIGATION, THE REPORTED ALARM COULD NOT BE IDENTIFIED AND THE CAUSE OF THE EVENT COULD NOT BE DETERMINED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN UNSPECIFIED ALARM OCCURRED ON THE HOMECHOICE DEVICE. THE HOME PATIENT WAS NOT CONNECTED AT THE TIME OF THE ALARM. IT WAS NOTED THAT THE HOMECHOICE ALARMED WITH POWER RESTORED WHEN THE MACHINE WAS TURNED ON. 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
    430650 HOMECHOICE PRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1