BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE

    MDR report key: 2201935 · Received August 11, 2011

    Report

    Report Number
    1423500-2011-10575
    Event Type
    Malfunction
    Date Received
    August 11, 2011
    Date of Event
    July 30, 2011
    Report Date
    July 30, 2011
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE HOMECHOICE (HC) DEVICE WAS RECEIVED FOR EVALUATION AT THE PRODUCT ANALYSIS LAB (PAL). THE REPORTED ISSUE OF INCREASED INTRA-PERITONEAL VOLUME (IIPV) WAS NOT CONFIRMED IN THE DEVICE LOGS AND WAS NOT DUPLICATED DURING THE PAL EVALUATION. THE DEVICE PASSED THE HOMECHOICE RETURN INSTRUMENT TEST / EVALUATION (RITE), FUNCTIONAL AND ELECTRICAL TESTS AND WAS FUNCTIONING WITHIN SPECIFICATION. A REVIEW OF THE DEVICE LOGS REVEALED NO DRAIN OR ULTRAFILTRATION (UF) VOLUMES THAT MEET THE IIPV CRITERIA. A CAUSE WAS UNDETERMINED. A LABELING REVIEW OF THE HOMECHOICE APD SYSTEMS PATIENT AT-HOME GUIDE ISSUED WAS FOUND TO BE ADEQUATE FOR THE USE ERROR(S) IN THE COMPLAINT. A DEVICE HISTORY REVEALED A FAILURE OF SYSTEM PNUEMATIC TEST. THE HC MACHINE WAS REWORKED AND PASSED ALL SUBSEQUENT TESTING PRIOR TO RELEASE. NO DEVICE FAILURE OR MALFUNCTION WAS IDENTIFIED THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. THIS ISSUE IS BEING INVESTIGATED THROUGH A 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

    A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER TO REQUEST ASSISTANCE ON THE HOME CHOICE (HC). PER THE INITIAL REPORT, THE REGISTERED NURSE (RN) STATED THE HOME PATIENT (HP) DRAINED OUT THE FILL VOLUME AND THEN DRAINED AN ADDITIONAL 1500ML WITH A MANUAL BAG FOR A TOTAL DRAIN VOLUME OF 3700ML. THE LARGEST PRESCRIBED FILL VOLUME (LPFV) IS 2200ML, THEREFORE THIS COMPLAINT MEETS THE OVERFILL CRITERIA. THERE WAS PATIENT INVOLVEMENT, BUT NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT.

    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 35 YR