BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE CYCLER-REFURBISHED

    MDR report key: 1880240 · Received October 22, 2010

    Report

    Report Number
    1423500-2010-04801
    Event Type
    Malfunction
    Date Received
    October 22, 2010
    Date of Event
    October 4, 2010
    Report Date
    October 4, 2010
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FKX
    PMA / PMN Number
    K053512
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTED DIFFICULTY OF AN INCREASED INTRAPERITONEAL VOLUMEI (IIPV), CONFIRMED IN THE DEVICE LOGS AS A DRAIN VOLUME OF 3658 ML DURING CYCLE 4 ON (B)(6) 2010, WAS NOT DUPLICATED DURING EVALUATION. THE DEVICE WAS DETERMINED TO MEET FUNCTIONAL AND ELECTRICAL PERFORMANCE SPECIFICATION REQUIREMENTS PER RETURNED INSTRUMENT TEST EVALUATION (RITE) TESTING. THE PRODUCT ANALYSIS LAB (PAL) EVALUATED THE DEVICE AND NO FAILURE OR MALFUNCTION WAS IDENTIFIED THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED DIFFICULTIES. THE DEVICE FUNCTIONED NORMALLY DURING PAL TESTING. THE ASSIGNABLE CAUSE OF THE REPORTED DIFFICULTY OF AN IIPV WAS DETERMINED TO BE: INSUFFICIENT DRAIN, FALSE EMPTY DETECT, USE ERROR, INAPPROPRIATE BYPASS OF THE LOW DRAIN VOLUME ALARM. THE PREVIOUS RETURN OF THE DEVICE WAS NOT FOR ANY ISSUES RELATED TO IIPV. A LABELING REVIEW FOUND THE PATIENT AT HOME GUIDE TO BE ADEQUATE FOR THE USE/USER ERROR IDENTIFIED IN THE INCIDENT. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION EXPECTED BUT NOT YET COMPLETED. ANY ADDITIONAL INFORMATION OR RESULTS OF EVALUATION WILL BE PROVIDED IN A FOLLOW UP E MDR.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER TO REPORT FEELING OVERFILLED WHILE DOING TIDAL THERAPY ON THE HOMECHOICE (HC) IN DRAIN 4 OF 4. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED THE TIDAL THERAPY AND THE WAY THE HC DRAINS. THE HOME PATIENT (HP) STATED THAT ON DRAIN 4 OF 4, SHE HAS SEEN A DRAIN VOLUME OF 3600ML. THE TSR WOULD SWAP THE HC. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT. ON (B)(6) 2010 PRODUCT SURVEILLANCE CONTACTED THE HP PERITONEAL DIALYSIS NURSE (PDN) REGARDING THE REPORT OF FEELING OVERFILLED. THE PDN STATED THEY HAVE SPOKEN WITH THE HP ABOUT THERAPY SETTINGS. THE PDN CONFIRMED THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS REPORT AND THAT THE HP WAS DOING WELL WITH THE FOLLOWING TREATMENTS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR