BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 3871745 · Received June 13, 2014

    Report

    Report Number
    1416980-2014-18870
    Event Type
    Malfunction
    Date Received
    June 13, 2014
    Report Date
    May 20, 2014
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SENTENCE "A REVIEW OF THE DEVICE HISTORY FOUND NO ERRORS DURING START UP." IS BEING CORRECTED TO " A REVIEW OF THE DEVICE HISTORY LOG IDENTIFIED SEVERAL ALARMS; HOWEVER, THEY COULD NOT BE IDENTIFIED AS THE REPORTED ISSUE AS THEY DID NOT OCCUR DURING START UP.". A REVIEW OF THE DEVICE HISTORY RECORDS REVEALED NO ISSUES THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED DIFFICULTY. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RECEIVED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY FOUND NO ERRORS DURING START UP. A VISUAL INSPECTION WAS PERFORMED ON THE DEVICE AND NO ISSUES WERE NOTED. THE DEVICE UNDERWENT FULL FUNCTIONAL TESTING, ELECTRICAL SAFETY TESTING, CALIBRATION, AND A SIMULATED THERAPY WITH NO ISSUES NOTED. THE DEVICE MET SPECIFICATIONS. A REVIEW OF THE DEVICE SERVICE HISTORY DID NOT IDENTIFY ANY PREVIOUS SERVICING EVENTS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). AS SEVERAL ALARMS WERE FOUND IN THE ALARM LOG, INCLUDING A CHECK HEATER LINE ALARM, THE REPORTED ISSUE OF AN UNKNOWN ALARM COULD BE VERIFIED. THE CAUSE OF THE ALARM WAS UNDETERMINED AS NO NON-CONFORMING PRODUCT WAS IDENTIFIED DURING SAMPLE ANALYSIS. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN UNKNOWN ERROR OCCURRED DURING USE ON THE HOME CHOICE (HC). THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ARRANGED THE RETURN OF THE DEVICE. 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
    350964 HOMECHOICE PRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1