BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE

    MDR report key: 4061667 · Received September 4, 2014

    Report

    Report Number
    1416980-2014-29627
    Event Type
    Malfunction
    Date Received
    September 4, 2014
    Date of Event
    August 11, 2014
    Report Date
    August 11, 2014
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RECEIVED BY BAXTER, BUT THE EVALUATION HAS NOT YET BEEN COMPLETED. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE EVALUATION OR IF ANY ADDITIONAL RELEVANT INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE HOMECHOICE DEVICE EVALUATION WAS COMPLETED FOR THE REPORTED INCREASED INTRA-PERITONEAL VOLUME (IIPV). AN EXTERNAL/INTERNAL INSPECTION WAS CONDUCTED AND FOUND NO ISSUES. THE DEVICE PASSED THE RETURN INSTRUMENT TEST/EVALUATION (RITE) FOR BOTH FUNCTIONAL AND ELECTRICAL TESTING. A SHORT SIMULATED THERAPY WAS PERFORMED WITH NO PROBLEMS IDENTIFIED. THE DEVICE WAS DETERMINED TO MEET PRODUCT SPECIFICATIONS RELATED TO THE REPORTED EVENT. THE SERVICE HISTORY REVIEW WAS CONDUCTED. WHILE THERE WAS A PAST IIPV EVENT DISCOVERED DURING SERVICE HISTORY REVIEW, NO HARDWARE ISSUES WERE FOUND THAT COULD HAVE CAUSED THE IIPV EVENT; THEREFORE, THE PAST SERVICING DID NOT CONTRIBUTE TO THIS IIPV OCCURRENCE. PER THE TROUBLESHOOTING WITH THE PATIENT, THEY WERE REPORTED TO HAVE PERFORMED A MANUAL DRAIN (WITHOUT THE HOMECHOICE DEVICE) AND THE SOLUTION AMOUNT WAS UNKNOWN. THE MANUAL DRAIN VOLUMES CANNOT BE RECORDED IN THE EVENT HISTORY LOG; THEREFORE, THE REPORTED EVENT COULD NOT BE VERIFIED THROUGH THE REVIEW OF THE EVENT HISTORY LOG. ALTHOUGH IT WAS REPORTED THAT THE PATIENT PERFORMED AN OFF-CYCLE EXCHANGE, THE VOLUMES WERE NOT RECORDED TO DETERMINE IF IT CAUSED THE IIPV EVENT. THE REPORTED EVENT COULD NOT BE VERIFIED AFTER THE REVIEW OF THE LOGS AND THE EVALUATION OF THE HOMECHOICE. THE CAUSE COULD NOT BE DETERMINED. IF ADDITIONAL RELEVANT INFORMATION IS OBTAINED, THEN A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HOME PATIENT (HP) HAD AN INCREASED INTRA-PERITONEAL VOLUME (IIPV) EVENT (INDICATES THAT THE PATIENT DRAIN VOLUME EXCEEDS 160% OF THE MAXIMUM PRESCRIBED CYCLE FILL VOLUME). AT THE TIME THE PATIENT CALLED, THE TOTAL FILL VOLUME WAS 2500ML WITH A LAST FILL VOLUME OF 2000ML. THE PATIENT STATED HE PERFORMED A MANUAL DRAIN OF 4000ML. 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
    542115 HOMECHOICE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR