BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 3941823 · Received July 17, 2014

    Report

    Report Number
    1416980-2014-23025
    Event Type
    Malfunction
    Date Received
    July 17, 2014
    Date of Event
    June 21, 2014
    Report Date
    June 22, 2014
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE HOMECHOICE (HC) WAS RETURNED AND AN EVALUATION WAS COMPLETED. AN EVENT HISTORY LOG REVIEW VERIFIED THE REPORTED DRAIN VOLUMES AND INCREASED INTRA-PERITONEAL VOLUME (IIPV) CONDITION. THE LOGS ALSO INDICATED THAT THE INITIAL DRAIN ALARM SETTING WAS SET TO 0ML. THE DEVICE WAS DETERMINED TO MEET FUNCTIONAL AND ELECTRICAL PERFORMANCE SPECIFICATION REQUIREMENTS PER RETURNED INSTRUMENT TEST/EVALUATION (RITE) TESTING. THE DEVICE PASSED BOTH THE HOMECHOICE RITE ELECTRICAL TEST AND THE RITE FUNCTIONAL TEST AND WAS DETERMINED TO MEET PERFORMANCE SPECIFICATION REQUIREMENTS PER RITE TESTING. EXTERNAL / INTERNAL INSPECTION REVEALED NO PROBLEMS. A CHECK OF THE PNEUMATIC SYSTEM FOUND THE PNEUMATIC SYSTEM WORKING TO SPECIFICATIONS. A SHORT SIMULATED THERAPY WAS PERFORMED AND PASSED SUCCESSFULLY. THERE WAS NO NON-CONFORMING PRODUCT IDENTIFIED RELATED TO THE REPORTED PROBLEM. THE CAUSE WAS FALSE EMPTY DETECT AND USE ERROR WITH INITIAL DRAIN ALARM SETTING INAPPROPRIATELY PROGRAMMED. THE HOMECHOICE / HOMECHOICE PRO APD SYSTEMS PATIENT AT-HOME GUIDE WARNS THAT 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 A HOME PATIENT (HP) FELT OVERFILLED DURING DWELL 1 OF AUTOMATED PERITONEAL DIALYSIS (APD) THERAPY USING A HOMECHOICE (HC) DEVICE. TROUBLESHOOTING REVEALED THAT THE HP PERFORMED A MANUAL FILL OF 2500ML PRIOR TO THERAPY. A TECHNICAL SERVICE REPRESENTATIVE (TSR) INSTRUCTED THE HP TO PERFORM A MANUAL DRAIN. THE MANUAL DRAIN VOLUME TOTALED 5405ML. THE PRESCRIBED FILL VOLUME WAS 3000ML. THE TSR INITIATED A SWAP OF THE DEVICE AND DISCUSSED THE USE OF CONTINUOUS AMBULATORY PERITONEAL DIALYSIS (CAPD) UNTIL A NEW DEVICE ARRIVED. 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
    419785 HOMECHOICE PRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR