BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 3844331 · Received June 2, 2014

    Report

    Report Number
    1416980-2014-17739
    Event Type
    Malfunction
    Date Received
    June 2, 2014
    Report Date
    May 9, 2014
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED TO BAXTER AND THE EVALUATION IS COMPLETE. A REVIEW OF THE EVENT LOG WAS PERFORMED. THE FOLLOWING ALARMS WERE NOTED IN THE ALARM LOG: RELOAD THE SET 201, RELOAD THE SET 202, SYSTEM ERROR (SE) 2044, SE 2265, AND SE 2201. AS THE OCCURRENCE DATE WAS UNKNOWN AND THE ERROR NOT SPECIFIED, THE REPORTED PROBLEM COULD NOT BE IDENTIFIED. A VISUAL INSPECTION AND FUNCTIONAL TESTING WERE PERFORMED. ELECTRICAL SAFETY TESTING, CALIBRATION, AND A SIMULATED THERAPY WERE PERFORMED WITH NO ISSUES FOUND. THE MEMBRANE GASKET, BOTTLE TUBING, AND BATTERY WERE REPLACED. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION: THE HOMECHOICE DEVICE RECEIVED A RETURNED INSTRUMENT TESTING EVALUATION (RITE). THIS EVALUATION INCLUDED FUNCTIONAL AND ELECTRICAL TESTING OF THE DEVICE. THE REPORTED UNKNOWN ALARM WAS DETERMINED TO BE A RELOAD THE SET 202 ALARM FOUND IN THE EVENT HISTORY LOG. THE CAUSE OF THE PROBLEM WAS THE MEMBRANE GASKET. TO CORRECT THE CONDITION, THE MEMBRANE GASKET WAS REPLACED. THE DEVICE WAS SENT FOR SERVICING. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN UNKNOWN SYSTEM ERROR OCCURRED DURING THERAPY ON THE HOMECHOICE. IT WAS NOT SPECIFIED WHEN IN THE THERAPY THIS OCCURRED. IT IS UNKNOWN IF THERE WAS PATIENT INVOLVEMENT; HOWEVER, THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321463 HOMECHOICE PRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1