BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PD CYCLER 110 VOLT HOME CHOICEPRO AUTOMATED

    MDR report key: 1971093 · Received January 26, 2011

    Report

    Report Number
    1423500-2011-01042
    Event Type
    Malfunction
    Date Received
    January 26, 2011
    Date of Event
    January 3, 2011
    Report Date
    January 3, 2011
    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). ON (B)(6) 2011 PRODUCT SURVEILLANCE SPOKE WITH THE HOME PATIENT'S NURSE WHO REPORTED THAT THE HOMECHOICE CYCLER HAS BEEN RETURNED TO BAXTER AS THE PATIENT IS NOW ON HEMODIALYSIS. NO FURTHER INFORMATION WAS PROVIDED. THE EVALUATION OF THE DEVICE HAS BEGUN; HOWEVER, HAS NOT YET BEEN COMPLETED. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE DEVICE EVALUATION, OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE PRODUCT ANALYSIS LABORATORY (PAL) WAS UNABLE TO CONFIRM IN THE LOGS THE REPORTED USE ERROR AND THE LOW DRAIN VOLUME WAS NOT DUPLICATED DURING THE PAL EVALUATION. BASED ON THE INFORMATION OBTAINED FROM INVESTIGATION BY BAXTER, THE ROOT CAUSE OF THE USE ERROR WAS NOT DETERMINED. THE LABELING REVIEW FOUND THE PATIENT AT HOME GUIDE TO E ADEQUATE FOR A USE/USER ERROR IDENTIFIED IN THIS INCIDENT. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORT HAS BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Additional Manufacturer Narrative · 1

    (B)(4). NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON THE COMPLETION OF BAXTER'S QUALITY REVIEW.

    Description of Event or Problem · 1

    DURING TROUBLESHOOTING FOR A RELATED REPORT, THE HOME PATIENT "("HP") STATED HE FELT HE" HAD BEEN IN DRAIN LONG ENOUGH SO HE BYPASSED TO FILL". "THE "TECHNICAL SERVICE REPRESENTATIVE " ("TSR") "ASSISTED THE HP TO REVIEW THE ALARM LOG WHICH SHOWED LOW DRAIN VOLUME ALARMS". "THE TSR ADVISED THE HP TO CONTACT HIS NURSE "("RN"). "THE HP STATED HE" WANTED TO END THERAPY". "THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION 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