BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 3873052 · Received June 13, 2014

    Report

    Report Number
    1416980-2014-18950
    Event Type
    Malfunction
    Date Received
    June 13, 2014
    Date of Event
    May 21, 2014
    Report Date
    May 21, 2014
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). THE HOMECHOICE (HC) WAS RECEIVED AND THE EVALUATION HAS BEEN COMPLETED. THE EVENT HISTORY LOG REVIEW SHOWED NO KEYSTROKES, PROGRAMMING, OR USE RELATED EVENTS THAT INDICATED AND/OR CONTRIBUTED TO THE REPORTED ISSUE. NO ABNORMALITIES WERE IDENTIFIED DURING INTERNAL/EXTERNAL INSPECTIONS. THE DEVICE PASSED AN INTERNAL/EXTERNAL INSPECTION. FUNCTIONAL TESTING IDENTIFIED A WEAK LITHIUM ION BATTERY AS WELL AS A SYSTEM ERROR (SE) 2364. THE CAUSE OF THE SE WAS DETERMINED TO BE THE MALFUNCTIONING LITHIUM ION BATTERY. THE BATTERY WAS SCRAPPED AND THE HC WAS SENT FOR SERVICING. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A HOMECHOICE (HC) PRO MACHINE SOUNDED AN UNKNOWN ALARM. THIS OCCURRED DURING AN UNKNOWN STEP OF PERITONEAL DIALYSIS (PD) THERAPY, WHILE THE PATIENT WAS CONNECTED. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) HAD THE HP CYCLE THE POWER ON THE HC MACHINE. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350097 HOMECHOICE PRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1