BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE

    MDR report key: 2791844 · Received October 15, 2012

    Report

    Report Number
    1416980-2012-02470
    Event Type
    Malfunction
    Date Received
    October 15, 2012
    Date of Event
    September 26, 2012
    Report Date
    September 26, 2012
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS NOT YET BEEN RECEIVED BUT AN EVALUATION IS EXPECTED. A FOLLOW-UP MDR WILL BE SUBMITTED UPON COMPLETION OF THE EVALUATION OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED AND EVALUATED BY THE PRODUCT ANALYSIS LAB. A REVIEW OF THE DEVICE LOGS CONFIRMED THE REPORTED INCREASED INTRA-PERITONEAL VOLUME (IIPV); HOWEVER, THE IIPV WAS NOT DUPLICATED DURING EVALUATION. THE DEVICE WAS DETERMINED TO MEET FUNCTIONAL AND ELECTRICAL PERFORMANCE SPECIFICATION REQUIREMENTS. NO DEVICE FAILURE OR MALFUNCTION WAS IDENTIFIED THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED IIPV. THE CAUSE OF THE IIPV WAS ONE OR MORE CYCLES ADVANCED TO THE NEXT FILL WHEN A SLOW/NO FLOW SITUATION OCCURRED ABOVE THE MINIMUM DRAIN VOLUME THRESHOLD. A DEVICE HISTORY REVIEW WAS PERFORMED WITH NO EXCEPTIONS DURING MANUFACTURING FOUND. THIS ISSUE IS BEING INVESTIGATED THROUGH CAPA.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED GLOBAL TECHNICAL SERVICES (GTS) REGARDING A HIGH DRAIN/CALL PD NURSE ALARM (INDICATES THE PATIENT DRAINED GREATER THAN 200% OF THE MAXIMUM PRESCRIBED CYCLE FILL VOLUME, MEETING INCREASED INTRA-PERITONEAL VOLUME (IIPV) CRITERIA), WHICH OCCURRED ON THE HOMECHOICE (HC) AFTER USE. THE HOME PATIENT (HP) STATED THAT WHEN THE MACHINE WAS TURNED ON FOR THERAPY TONIGHT IT ALARMED "HIGH DRAIN". THE TECHNICAL SERVICE REPRESENTATIVE (TSR) HAD THE HP PRESS THE GO BUTTON TO RETRIEVE THE PROGRAMMING INFORMATION BUT THE HP STATED THAT THE MACHINE WAS NOT RESPONDING. THE MACHINE IS BEING SENT IN FOR FURTHER EVALUATION. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT. PRODUCT SURVEILLANCE (PS) SPOKE WITH THE REGISTERED NURSE (RN) ON (B)(6) 2012 REGARDING THE REPORTED ALARM. THE NURSE WAS NOT AWARE OF THE ALARM. SHE DID NOT KNOW OF ANY ISSUES THE PATIENT WAS HAVING IN RELATION TO THE OVERFILL. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED IN ASSOCIATION WITH THE OVERFILL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR HOMECHOICE AUTOMATED PD SET WITH CASSETTE