BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PD CYCLER 110 VOLT HOME CHOICEPRO AUTOMATED

    MDR report key: 1810501 · Received August 20, 2010

    Report

    Report Number
    1423500-2010-02776
    Event Type
    Malfunction
    Date Received
    August 20, 2010
    Date of Event
    July 25, 2010
    Report Date
    August 9, 2010
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K053512
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE PASSED THE HOMECHOICE RITE (RETURN INSTRUMENT TEST / EVALUATION) FUNCTIONAL AND ELECTRICAL TESTS AND WAS FUNCTIONING WITHIN SPECIFICATION. THE PRODUCT ANALYSIS LAB (PAL) EVALUATED THE DEVICE. THE POWER WAS CYCLED SEVERAL TIMES AND NO PROBLEMS ENCOUNTERED. THE COVER WAS OPENED AND AN INTERNAL INSPECTION PERFORMED. NO PROBLEMS WERE REVEALED DURING THIS INSPECTION AND ALL CONNECTIONS WERE CORRECT AND SECURE. THE BATTERY BACKUP VOLTAGE AND DIGITAL BOARD VOLTAGE AT TP 4 MEASURED WITHIN SPECIFICATION. A REVIEW OF THE DEVICE LOGS REVEALED ONE INSTANCE OF IIPV (INCREASED INTRA-PERITONEAL VOLUME). THE PROBABLE CAUSE FOR THE IIPV FOUND IN THE LOGS WAS DETERMINED TO BE INSUFFICIENT DRAIN: FALSE EMPTY DETECT AND USE ERROR: CLINICIAN INAPPROPRIATELY SET MINIMUM DRAIN VOLUME PERCENTAGE SETTING TOO LOW. A SERVICE HISTORY REVIEW WAS PERFORMED, BUT NO ISSUES WERE IDENTIFIED THAT MAY HAVE CONTRIBUTED TO THE ISSUE OF IIPV AND THE DEVICE HAD NOT BEEN PREVIOUSLY RETURNED FOR ANY ISSUES RELATED TO IIPV. A LABELING REVIEW FOUND THE LABELING TO BE ADEQUATE FOR THE USE/USER ERROR IDENTIFIED IN THIS 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). PRODUCT SURVEILLANCE SPOKE WITH THE PERITONEAL DIALYSIS (PD) REGISTERED NURSE (RN) ON (B)(6) 2011 AND PROVIDED THE RESULTS OF THE EVALUATION. THE PD RN STATED THE PATIENT DID NOT HAVE ANY SYMPTOMS AROUND THE TIME OF THE INCIDENT. THE PATIENT HAD A DAY DWELL ADDED IN (B)(6) AND THE INITIAL DRAIN ALARM HAS BEEN SET APPROPRIATELY. THE PATIENT HAS BEEN FINE AND CONTINUING THERAPY ON THE CYCLER WITH NO FURTHER ISSUES.

    Additional Manufacturer Narrative · 1

    (B)(4). A FOLLOW-UP REPORT WILL BE SUBMITTED UPON EVALUATION COMPLETION OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    AN INCREASED INTRA-PERITONEAL VOLUME (IIPV) SITUATION WAS IDENTIFIED IN THE LOG OF A HOMECHOICE (HC) DEVICE. THE IIPV OCCURRED ON (B)(6) 2010 DURING DRAIN CYCLE 6. THE FILL VOLUME WAS 2000ML AND THE TOTAL DRAIN VOLUME WAS 3208ML WHICH MEETS IIPV CRITERIA. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PD CYCLER 110 VOLT HOME CHOICEPRO AUTOMATED SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR