BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE

    MDR report key: 2781081 · Received October 10, 2012

    Report

    Report Number
    1416980-2012-01997
    Event Type
    Malfunction
    Date Received
    October 10, 2012
    Date of Event
    September 20, 2012
    Report Date
    September 20, 2012
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    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). 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. THIS ISSUE IS BEING INVESTIGATED THROUGH CAPA.

    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.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING A HIGH DRAIN 107/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 THEY CALLED THE REGISTERED NURSE (RN) AND THE RN DIDN'T KNOW HOW TO CLEAR THE ALARM. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) REVIEWED THE PREVIOUS NIGHT'S THERAPY. THE CYCLE 7 ULTRAFILTRATION (UF) WAS EQUAL TO 2905ML, AND THE HP'S FILL VOLUME WAS EQUAL TO 2500ML. THE HP STATED THAT IT IS NOT UNCOMMON FOR THEM TO HAVE A BIG DRAIN IN THEIR LAST DRAIN. THEY STATED THAT THEY DIDN'T NOTICE OR HAVE ANY SYMPTOMS. 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 STATED THAT SHE WAS AWARE OF THE ALARM. THE NURSE STATED THAT THE PATIENT HAS NOT REPORTED ANY OTHER ISSUES WITH THERAPY. SHE STATED THAT AS FAR AS SHE KNEW, THE PATIENT DID NOT HAVE ANY REOCCURRENCES OF THE ALARM. THE NURSE STATED THAT THE PATIENT HAS BEEN ABLE TO CONTINUE THERAPY ON THE CYCLER SUCCESSFULLY. THERE WAS NO PATIENT INJURY REPORTED. NO ALLEGATIONS WERE MADE AGAINST ANY BAXTER PRODUCTS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR HOMECHOICE AUTOMATED PD SET WITH CASSETTE