BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 3802717 · Received May 9, 2014

    Report

    Report Number
    1416980-2014-14969
    Event Type
    Malfunction
    Date Received
    May 9, 2014
    Report Date
    April 15, 2014
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AFTER FURTHER INVESTIGATION, IT WAS DETERMINED THE REPORTED PROBLEM WAS A POWER FAILURE. THE CAUSE OF THE ISSUE WAS DETERMINED TO BE A DEPLETED LEAD ACID BATTERY. THE BATTERY WAS SCRAPPED AND THE DEVICE WAS SENT FOR SERVICING. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    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 WITH THE FOLLOWING ALARMS NOTED: (B)(6) 2014 20:50:20 CHECK SUPPLY LINE, (B)(6) 2014 17:18:45 CHECK SUPPLY LINE, (B)(6) 2014 17:15:07 CHECK SUPPLY LINE, 12/03/13 11:06:29 CHECK PATIENT LINE, (B)(6) 2013 02:24:42 LOW DRAIN VOLUME, AND (B)(6) 2013 07:06:18 LOW DRAIN VOLUME. NUMEROUS BATTERY FAILED LISTED IN THE EVENT LOG. A VISUAL INSPECTION WAS PERFORMED. FUNCTIONAL TESTING WAS PERFORMED WITH NO ISSUES NOTED. 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 THE PARTS REPLACED DURING SERVICING CAUSED OR CONTRIBUTED TO THE REPORTED DIFFICULTY. THE REPORTED PROBLEM COULD NOT BE IDENTIFIED THROUGH THE SAMPLE EVALUATION. 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

    AN UNKNOWN FAILURE WAS REPORTED TO HAVE OCCURRED DURING THE USE OF THE HOMECHOICE DEVICE. THERE WAS NO PATIENT INJURY REPORTED TO BE IN ASSOCIATION WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280550 HOMECHOICE PRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1