BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 3902544 · Received June 30, 2014

    Report

    Report Number
    1416980-2014-20845
    Event Type
    Malfunction
    Date Received
    June 30, 2014
    Date of Event
    June 5, 2014
    Report Date
    June 5, 2014
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE HOMECHOICE (HC) EVALUATION WAS COMPLETED. THE EVENT HISTORY LOG REVIEW IDENTIFIED SEVERAL OCCURRENCES OF A LOW DRAIN VOLUME ALARM ON THE REPORTED THERAPY DATE. NO ABNORMALITIES WERE IDENTIFIED DURING INTERNAL/EXTERNAL INSPECTIONS. THE DEVICE PASSED RITE (RETURNED INSTRUMENT TEST EVALUATION) ELECTRICAL TESTING, BUT FAILED RITE FUNCTIONAL TESTING FOR AN UNRELATED ISSUE. ALL PRESSURES OF THE PNEUMATIC SYSTEM WERE WITHIN SPECIFICATION LIMITS AND STABLE. THE REPORTED UNKNOWN ALARM WAS VERIFIED IN THE LOGS AS A LOW DRAIN VOLUME ALARM, BUT NO NONCONFORMING PRODUCT RELATED TO THE DISCOVERED ALARM WAS IDENTIFIED DURING SAMPLE ANALYSIS. THE CAUSE OF THE LOW DRAIN VOLUME ALARM WAS UNDETERMINED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED AND IS CURRENTLY IN THE PROCESS OF BEING EVALUATED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HOME PATIENT (HP) HAD AN UNKNOWN ALARM ON THE HOMECHOICE (HC) DEVICE DURING AN UNKNOWN STEP OF PERITONEAL DIALYSIS (PD) THERAPY. IT WAS UNKNOWN IF THE HP WAS CONNECTED AT THE TIME OF THE ALARM. THE HP WOULD COMPLETE THERAPY VIA CONTINUOUS AMBULATORY PERITONEAL DIALYSIS (CAPD). THERE WAS NO REPORT OF PATIENT INJURY, MEDICAL INTERVENTION, OR ADVERSE EVENT ASSOCIATED WITH THIS REPORT. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    380873 HOMECHOICE PRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1