BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 3821272 · Received May 20, 2014

    Report

    Report Number
    1416980-2014-16248
    Event Type
    Malfunction
    Date Received
    May 20, 2014
    Date of Event
    April 25, 2014
    Report Date
    April 25, 2014
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RECEIVED FOR EVALUATION. INTERNAL AND EXTERNAL VISUAL INSPECTION WAS PERFORMED WITH NO ISSUES NOTED. THE EVENT HISTORY LOG REVIEW SHOWED NO KEYSTROKES, PROGRAMMING, OR USE RELATED EVENTS THAT INDICATED AND/OR CONTRIBUTED TO THE EVENT. THE DEVICE PASSED THE RETURNED INSTRUMENT TESTING EVALUATION (RITE) ELECTRICAL TEST. THE PNEUMATIC SYSTEM WAS TESTED AND IT THE PRESSURES WERE CORRECT AND STABLE. SIMULATED THERAPY WAS PERFORMED AND COMPLETED SUCCESSFULLY. A REVIEW OF THE SERVICE HISTORY REVEALED NO INDICATION THAT THE PARTS REPLACED DURING SERVICING CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. NO DEVICE FAILURE OR MALFUNCTION WAS IDENTIFIED DURING EVALUATION. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RECEIVED FOR EVALUATION. UPON COMPLETION OF THE DEVICE EVALUATION, OR IF ANY ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A HOME PATIENT (HP) SMELLED AN ODOR LIKE PLASTIC BURNING DURING THERAPY ON THE HOMECHOICE. THE TECHNICAL SERVICE REPRESENTATIVE ARRANGED A SWAP OF THE DEVICE. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS INDICATED AS A RESULT OF THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300280 HOMECHOICE PRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR