BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE CYCLER-REFURBISHED

    MDR report key: 1905045 · Received November 22, 2010

    Report

    Report Number
    1423500-2010-05999
    Event Type
    Malfunction
    Date Received
    November 22, 2010
    Date of Event
    October 24, 2010
    Report Date
    October 26, 2010
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K053512
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). TWO OF 3 EMDRS. THE DEVICE HAS BEEN RECEIVED AT BAXTER FOR EVALUATION. HOWEVER, THE EVALUATION IS NOT COMPLETE AT THIS TIME. A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF THE DEVICE EVALUATION, OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE HOMECHOICE (HC) DEVICE WAS RECEIVED AND EVALUATED. THE DEVICE WAS DETERMINED TO MEET THE PERFORMANCE SPECIFICATION REQUIREMENTS. THE REPORTED ISSUE OF FAILURE TO ALARM WAS CONFIRMED IN THE DEVICE LOGS, BUT NOT DUPLICATED DURING PAL TESTING. THE CAUSE OF FAILURE TO ALARM WAS UNDETERMINED. A SERVICE HISTORY REVIEW (SHR) REVEALED THAT NO ISSUES THAT MAY HAVE CONTRIBUTED TO THE REPORTED PROBLEM OF FAILURE TO ALARM. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    DURING TROUBLESHOOTING THE CUSTOMER'S REPORTED ISSUE HOMECHOICE (HC) MACHINE NOT DRAINING HIM DURING INITIAL DRAIN, THE HOME PATIENT (HP) REVEALED THAT THE HC MACHINE DID NOT ALARM EITHER THE HP ADDED THAT DURING THE INITIAL DRAIN THE NUMBERS HOVER BETWEEN 26 ML AND BACK TO 17 ML. THE HP HAD A LAST FILL OF 2 L AND THE INITIAL DRAIN ALARM IS SET TO 1200 ML. THE HP HAD BEEN HAVING THIS PROBLEM SINCE THE PAST THREE NIGHTS AND ADDED THAT HE END UP GETTING OFF THE HC MACHINE AND USE MANUAL SUPPLIES. PER INITIAL REPORT, THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ARRANGED A SWAP OF THE INSTRUMENT DUE TO THIS ISSUE. THE HP WOULD CALL THE NURSE REGARDING MISSED THERAPY AND THE SWAP OF THE HC MACHINE. DURING A FOLLOW UP WITH THE HP REGARDING THE REPORTED ISSUE, IT WAS REVEALED THAT THE ISSUE HAD BEEN RESOLVED SINCE THE HC MACHINE WAS REPLACED. THE HP EXPLAINED THAT THE TWO NIGHTS PRIOR TO THE TIME HE HAD CALLED BAXTER WAS THE SAME ISSUE IN TERMS OF HP NOT DRAINING ENOUGH AND THE HC MACHINE CONTINUING WITHOUT ALARMING. THE HP'S PRESCRIBED FILL VOLUME IS 2500 ML. THE HP DID NOT REMEMBER THE EXACT AMOUNT OF FLUID HE DRAINED MANUALLY BECAUSE OF THE VERY LITTLE INITIAL DRAIN. HOWEVER, THE HP VERIFIED THAT THE MANUAL DRAIN AMOUNT DID NOT EXCEED 2500 ML. THE HP STATED THAT HE IS DOING FINE AND CONTINUING THERAPY WITHOUT ANY FURTHER ISSUES. THE HP STATED THAT HE DID NOT HAVE ANY INJURY OR HARM AS A RESULT OF THIS INCIDENT. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS INDICATED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 52 DA