BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE

    MDR report key: 4090120 · Received September 15, 2014

    Report

    Report Number
    1416980-2014-31302
    Event Type
    Malfunction
    Date Received
    September 15, 2014
    Date of Event
    August 21, 2014
    Report Date
    August 21, 2014
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED TO BAXTER AND AN EVALUATION WAS PERFORMED TO INVESTIGATE THE REPORTED UNKNOWN ALARM. AN EVENT HISTORY LOG REVIEW WAS PERFORMED AND A LOW DRAIN VOLUME ALARM WAS IDENTIFIED. A VISUAL INSPECTION WAS PERFORMED WITH NO ISSUES NOTED. THE DEVICE PASSED THE POWER UP SELF-TEST. A LOW DRAIN VOLUME ALARM OCCURRED DURING THE FUNCTIONAL TEST. THE REPORTED ISSUE WAS VERIFIED DURING THE EVENT HISTORY LOG REVIEW AND SAMPLE EVALUATION TASKS. UPON CONCLUSION OF THE INVESTIGATION, THE ASSIGNABLE CAUSE FOR THE REPORTED ISSUE WAS DETERMINED TO BE THE MEMBRANE GASKET. THE MEMBRANE GASKET WAS REPLACED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4).THE DEVICE HAS BEEN RECEIVED AND EVALUATION IS UNDERWAY. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A CUSTOMER EXPERIENCED AN UNKNOWN ALARM ON THE HOMECHOICE MACHINE. THIS OCCURRED DURING USE. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    569807 HOMECHOICE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1