BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 4191137 · Received October 21, 2014

    Report

    Report Number
    1416980-2014-36837
    Event Type
    Malfunction
    Date Received
    October 21, 2014
    Date of Event
    September 26, 2014
    Report Date
    September 26, 2014
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED TO BAXTER, AND AN EVALUATION IS COMPLETE. AN EVENT HISTORY LOG REVIEW WAS PERFORMED AND COULD NOT VERIFY THE REPORTED ISSUE. A SERVICE HISTORY RECORD REVIEW DID NOT IDENTIFY ANY ISSUES IN THE PREVIOUS SERVICE EVENTS THAT WOULD HAVE CONTRIBUTED TO THE REPORTED ISSUE. NO ABNORMALITIES WERE IDENTIFIED DURING THE INTERNAL AND EXTERNAL INSPECTIONS. THE DEVICE RECEIVED A RETURNED INSTRUMENT TEST EVALUATION (RITE), WHICH INCLUDED ELECTRICAL AND FUNCTIONAL TESTING OF THE DEVICE. THE DEVICE PASSED RITE ELECTRICAL TESTING, BUT FAILED RITE FUNCTIONAL TESTING DUE TO AN UNRELATED ISSUE. ALTHOUGH RITE FUNCTIONAL TESTING FAILED, THE FAILURE WOULD NOT HAVE PRODUCED THE REPORTED CONDITION. UPON COMPLETION OF THE INVESTIGATION, THE REPORTED UNKNOWN ALARM WAS UNABLE TO BE VERIFIED AND ITS CAUSE UNDETERMINED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED AN UNKNOWN ALARM OCCURRED ON A HOMECHOICE (HC) DEVICE WHILE PERFORMING AUTOMATED PERITONEAL DIALYSIS THERAPY. A TECHNICAL SERVICE REPRESENTATIVE INITIATED A SWAP OF THE HC AND DISCUSSED THE USE OF CONTINUOUS AMBULATORY PERITONEAL DIALYSIS UNTIL A NEW HC ARRIVED. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE REPORT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    669484 HOMECHOICE PRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR