BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 2230339 · Received September 1, 2011

    Report

    Report Number
    1423500-2011-11510
    Event Type
    Malfunction
    Date Received
    September 1, 2011
    Date of Event
    August 9, 2011
    Report Date
    August 9, 2011
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR PROGRAM CHANGED BY DEVICE WAS NOT CONFIRMED. BASED ON THE INFORMATION GATHERED DURING BAXTER'S INVESTIGATION, THE ROOT CAUSE OF THE REPORT WAS UNDETERMINED. A SERVICE HISTORY REVIEW REVEALED NO PREVIOUS SERVICE EVENTS THAT WERE RELATED TO THE REPORTED CONDITION. A DEVICE HISTORY RECORD REVIEW IDENTIFIED NO ISSUES THAT WERE RELATED TO THE REPORTED CONDITION.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT AVAILABLE FOR EVALUATION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    THE PATIENT CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING THEIR MACHINE SHOWING 81 CYCLES INSTEAD OF 5, WHICH OCCURRED ON THE HOMECHOICE DURING USE. THE PATIENT STATED THEY NORMALLY HAD 5 CYCLES ON THEIR MACHINE AND AT THE TIME OF THE CALL THE MACHINE WAS SHOWING THE PATIENT HAD 81 CYCLES. THE PATIENT WANTED THE CYCLES CHANGED BACK TO 5. THE BAXTER TECHNICAL SERVICE REPRESENTATIVE EXPLAINED THAT THE PATIENT WOULD NEED TO CONTACT THEIR NURSE AT THE CLINIC TO GET THE CYCLES CHANGED. THE PATIENT UNDERSTOOD AND WOULD CONTACT THEIR NURSE. THERE WAS PATIENT INVOLVEMENT BUT THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT. BAXTER PRODUCT SURVEILLANCE CONTACTED THE PERITONEAL DIALYSIS REGISTERED NURSE (PD RN) ON (B)(6) 2011 REGARDING THE REPORT OF THE PATIENT'S CYCLER DISPLAYING 81 CYCLES INSTEAD OF 5. THE PD RN STATED THAT THEY WERE NOT MADE AWARE OF THE ISSUE AND STATED THAT THEY HAD SEEN THE PATIENT SINCE THEN AND NOTHING WAS MENTIONED. THE PD RN STATED THE PATIENT MUST HAVE RESOLVED THE ISSUE AND AS FAR AS THEY KNEW THE PATIENT WAS CONTINUING THERAPY ON THE CYCLER SUCCESSFULLY. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED. NO FURTHER INFORMATION WAS AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR