BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 3962055 · Received July 28, 2014

    Report

    Report Number
    1416980-2014-24513
    Event Type
    Malfunction
    Date Received
    July 28, 2014
    Date of Event
    July 3, 2014
    Report Date
    July 3, 2014
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A REVIEW OF THE DEVICE HISTORY RECORDS REVEALED NO FAILURES OR MALFUNCTIONS RELATED TO THE REPORTED EVENT. AS THE DEVICE WAS NOT RETURNED, A COMPLETE DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE HOMECHOICE (HC) WAS REPORTED TO BE UNAVAILABLE FOR EVALUATION. A DEVICE HISTORY RECORD/SERVICE HISTORY RECORD REVIEW WILL BE PERFORMED. IF 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) FELT OVERFILLED WHILE PERFORMING AUTOMATED PERITONEAL DIALYSIS (APD) ON A HOMECHOICE (HC) DEVICE. TROUBLESHOOTING REVEALED THAT THE HP PERFORMED AN OFF CYCLER EXCHANGE OF 2500ML, BUT HAD THE INITIAL DRAIN ALARM SETTING SET TO 10ML. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) INSTRUCTED THE HP TO PERFORM A MANUAL DRAIN WHICH TOTALED APPROXIMATELY 4562ML. THE REPORTED MAXIMUM PRESCRIBED FILL VOLUME WAS ONLY 2500ML. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE REPORT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    437834 HOMECHOICE PRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1