BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 3851474 · Received June 5, 2014

    Report

    Report Number
    1416980-2014-17995
    Event Type
    Malfunction
    Date Received
    June 5, 2014
    Report Date
    May 12, 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 HOMECHOICE (HC) WAS RETURNED AND A DEVICE ANALYSIS HAS BEEN COMPLETED. AN EVENT HISTORY LOG REVIEW IDENTIFIED SEVERAL SYSTEM ERROR (SE) 1026 (POSITIVE T TANK LOW) ALARMS. NO ABNORMALITIES WERE IDENTIFIED DURING INTERNAL/EXTERNAL INSPECTIONS. DURING FUNCTIONAL TESTING THE 552 MONITOR MICROPROCESSOR DETECTED THAT THE PRESSURE IN THE TANK WHICH SEALS THE DOORS WAS BELOW SPECIFICATION LIMITS. THE CAUSE OF THE ISSUE WAS DETERMINED TO BE A MALFUNCTIONING MEMBRANE GASKET AND MANIFOLD VALVES. THE MEMBRANE GASKET AND MANIFOLD VALVES WERE SCRAPPED. THE DEVICE WAS SENT FOR SERVICING. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RECEIVED BUT THE EVALUATION HAS YET TO BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT UNSPECIFIED SYSTEM ERRORS 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
    329234 HOMECHOICE PRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1