BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 3030986 · Received April 2, 2013

    Report

    Report Number
    1416980-2013-08101
    Event Type
    Malfunction
    Date Received
    April 2, 2013
    Date of Event
    March 10, 2013
    Report Date
    March 10, 2013
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS EVALUATED BY BAXTER. A VISUAL INSPECTION WAS PERFORMED WITH NO ISSUES NOTED. THE REPORTED PROBLEM WAS NOT REPRODUCED DURING FUNCTIONAL TESTING. THE REPORTED ISSUE WAS CONFIRMED IN THE EVENT HISTORY LOG REVIEW. THE CAUSE WAS DETERMINED TO BE USE ERROR, TIDAL TOTAL UF REMOVAL SET TOO LOW DUE TO USE OF HIGHER DEXTROSE SOLUTION THAN USUAL. A REVIEW OF THE LABEL FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN REQUESTED FOR EVALUATION. A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF A DEVICE EVALUATION, OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN INCREASED INTRA-PERITONEAL VOLUME (IIPV) EVENT OCCURRED ON A HOMECHOICE MACHINE DURING PERITONEAL DIALYSIS (PD) THERAPY. THE HOME PATIENT (HP) STATED THE MACHINE ALARMED "HIGH DRAIN CALL PD NURSE" AT THE END OF THERAPY. THE HP STATED THEIR ULTRAFILTRATION (UF) WAS 1604ML AND THEY USED 2.5% DEXTROSE SOLUTION, BUT THE HP USUALLY USED 1.5% DEXTROSE SOLUTION. THE TECHNICAL SERVICES REPRESENTATIVE (TSR) EXPLAINED THAT THE ALARM. THERE WAS PATIENT INVOLVEMENT, BUT NO CLINICAL CONSEQUENCES FOR THE PATIENT WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134878 HOMECHOICE PRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1