BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 3843784 · Received June 2, 2014

    Report

    Report Number
    1416980-2014-17661
    Event Type
    Malfunction
    Date Received
    June 2, 2014
    Date of Event
    May 8, 2014
    Report Date
    May 8, 2014
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RECEIVED FOR EVALUATION. THE DEVICE HISTORY AND SERVICE HISTORY WERE REVIEWED WITH NO DEFECTS NOTED. THE REPORTED PROBLEM COULD NOT BE VERIFIED. 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 ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD AN UNKNOWN ALARM ON THE HOMECHOICE (HC) PRO MACHINE DURING AN UNSPECIFIED STEP OF PERITONEAL DIALYSIS (PD) THERAPY. PATIENT CONNECTION AT THE TIME OF THE ALARM IS UNKNOWN. THE REPORTER STATED THAT THE ALARM WAS UNABLE TO BE CLEARED. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321499 HOMECHOICE PRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1