BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 3984234 · Received August 6, 2014

    Report

    Report Number
    1416980-2014-25455
    Event Type
    Malfunction
    Date Received
    August 6, 2014
    Date of Event
    July 12, 2014
    Report Date
    July 12, 2014
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. AN INTERNAL/EXTERNAL INSPECTION WAS PERFORMED WITH NO PROBLEMS NOTED. THE DEVICE PASSED BOTH FUNCTIONAL AND ELECTRICAL RETURNED INSTRUMENT TESTING EVALUATION (RITE). THE DEVICE'S PNEUMATIC SYSTEM WAS TESTED, AND ALL PRESSURES WERE CORRECT AND STABLE. A SHORT SIMULATED THERAPY WAS PERFORMED AND COMPLETED SUCCESSFULLY. THE EVENT HISTORY LOG REVIEW WAS PERFORMED AND IDENTIFIED A HIGH DRAIN VOLUME 101 ALARM. THE ALARM OCCURRED ON (B)(6) 2014 AT 02:16:32. THE CAUSE WAS DETERMINED TO BE A FALSE EMPTY DETECT AND USE ERROR OF INAPPROPRIATELY PROGRAMMING THE INITIAL DRAIN ALARM SETTING. HOMECHOICE / HOMECHOICE PRO APD SYSTEMS PATIENT AT-HOME GUIDE STATES IN THE WARNINGS: ¿SETTING THE I-DRAIN ALARM VOLUME TOO LOW OR OFF CAN RESULT IN AN INCOMPLETE INITIAL DRAIN FOLLOWED BY A FULL FILL. THIS CAN RESULT IN AN INCREASED INTRAPERITONEAL VOLUME (IIPV) SITUATION.¿ A FORMAL REVIEW OF THE LABEL FOR THE PRODUCT FAMILY WILL BE CONDUCTED. 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) RECEIVED A HIGH DRAIN ALARM DURING SETUP FOR PERITONEAL DIALYSIS (PD) THERAPY ON THE HOMECHOICE (HC) MACHINE. THE ALARM OCCURRED WHEN THE DEVICE WAS TURNED ON A HIGH DRAIN ALARM INDICATES THE PATIENT DRAINED GREATER THAN 200% OF THE MAXIMUM PRESCRIBED CYCLE FILL VOLUME. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED THE MEANING OF THE ALARM TO THE CARE GIVER (CG) AND ASSISTED THEM IN CLEARING IT BY CYCLING THE POWER ON THE HC DEVICE. THE HP WAS TO COMPLETE THERAPY USING CONTINUOUS AMBULATORY PERITONEAL DIALYSIS (CAPD). THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION CAUSALLY RELATED TO THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    461140 HOMECHOICE PRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR