BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 5414080 · Received February 5, 2016

    Report

    Report Number
    1416980-2016-02768
    Event Type
    Malfunction
    Date Received
    February 5, 2016
    Date of Event
    January 22, 2016
    Report Date
    February 26, 2016
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PATIENT'S DRAIN VOLUME FOR CYCLE ONE WAS 4338ML AND THE LARGEST PRESCRIBED FILL VOLUME WAS 2000ML. THE DEVICE WAS RECEIVED AND AN EVALUATION WAS PERFORMED TO INVESTIGATE THE REPORTED EVENT. A REVIEW OF THE EVENT HISTORY LOG VERIFIED THE OCCURRENCE OF AN INCREASED INTRA-PERITONEAL VOLUME (IIPV) EVENT. AN EXTERNAL/INTERNAL INSPECTION WAS PERFORMED AND FOUND NO ISSUES. THE HOMECHOICE DEVICE RECEIVED A RETURNED INSTRUMENT TESTING EVALUATION (RITE). THIS EVALUATION INCLUDED FUNCTIONAL AND ELECTRICAL TESTING OF THE DEVICE. THE DEVICE WAS DETERMINED TO MEET FUNCTIONAL AND ELECTRICAL PERFORMANCE SPECIFICATION REQUIREMENTS PER RITE TESTING. A SHORT SIMULATED THERAPY WAS PERFORMED SUCCESSFULLY. UPON CONCLUSION OF THE INVESTIGATION, THE CAUSE OF THE REPORTED ISSUE WAS DETERMINED TO BE FALSE EMPTY DETECT AND USE ERROR WITH THE INITIAL DRAIN ALARM SETTING INAPPROPRIATELY PROGRAMMED. THE HOMECHOICE AND 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 REVIEW OF THE LABEL FOR THE PRODUCT FAMILY WILL BE CONDUCTED. SHOULD ADDITIONAL RELEVANT ADDITIONAL INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4) THE DEVICE HAS BEEN RECEIVED AND THE EVALUATION IS IN PROGRESS. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER TO REGARDING A HIGH DRAIN 101 ALARM, WHICH OCCURRED ON THE HOMECHOICE MACHINE DURING USE DURING DRAIN ONE OF PERITONEAL DIALYSIS THERAPY. A HIGH DRAIN 101 ALARM INDICATES THE PATIENT DRAINED GREATER THAN 200% OF THE MAXIMUM PRESCRIBED CYCLE FILL VOLUME, MEETING INCREASED INTRA-PERITONEAL VOLUME CRITERIA. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) REVIEWED THE NUMBERS. THE (TSR) EXPLAINED WHY THE PATIENT WAS OVERFILLED. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) DISCUSSED THE USE OF CONTINUOUS AMBULATORY PERITONEAL DIALYSIS (CAPD) UNTIL THE NEW MACHINE ARRIVES. 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
    71572 HOMECHOICE PRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR