BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PD CYCLER 110 VOLT HOME CHOICEPRO AUTOMATED

    MDR report key: 1973479 · Received January 31, 2011

    Report

    Report Number
    1423500-2011-01286
    Event Type
    Malfunction
    Date Received
    January 31, 2011
    Date of Event
    January 6, 2011
    Report Date
    January 6, 2011
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K053512
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE IS NOT AVAILABLE FOR EVALUATION. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THEN A FOLLOW UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE CAUSE FOR THE THERAPY SHORTENED FROM 5 TO 4 CYCLES WAS UNDETERMINED. THE DEVICE'S SERVICE HISTORY RECORD WAS REVIEWED AND NO ISSUES WERE IDENTIFIED THAT MAY HAVE CONTRIBUTED TO THE DEVICE CHANGING THE CYCLES. 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

    A CUSTOMER CONTACTED GLOBAL TECHNICAL SERVICES (GTS) REGARDING THE HOMECHOICE (HC) UNIT SHORTENING THE NUMBER OF CYCLES DURING USE. THE HOME PATIENT (HP) REPORTED THAT THE CYCLES IN HIS THERAPY HAD SHORTENED FROM 5 TO 4 CYCLES. HP WANTED TO KNOW IF IT IS POSSIBLE THAT THE MACHINE BYPASSES ON IT'S OWN. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED THE POSSIBILITIES OF WHY CYCLES WOULD BE SHORTENED AND INSTRUCTED HP TO CALL BAXTER AT TIME OF THE EVENT TO TROUBLESHOOT. THERE WAS PATIENT INVOLVEMENT. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED. PRODUCT SURVEILLANCE FOLLOWED UP WITH THE HP'S NURSE ON (B)(4) 2011 REGARDING THE REPORTED PROBLEM. THE NURSE STATED, HP WAS IN THE CLINIC YESTERDAY AND HE DID INFORM HER ABOUT THE ISSUE WITH THE HC SHORTENING THE NUMBER OF CYCLES. THE NURSE SAID THAT IT DOES APPEAR THAT THE HC SHORTENED THE NUMBER OF CYCLES BUT THAT THE HP'S THERAPY STILL ENDS UP BEING THE SAME, CORRECT EVERY TIME. THE NURSE STATED THEY MADE SURE THE HP WAS COMFORTABLE USING THE HC AND ISN'T JUST "PUSHING BUTTONS" AND THE HP APPEARED PRETTY COMFORTABLE WITH USING THE HC. THE NURSE STATED HP DID NOT SWAPPED OUT THE HC AND DOESN'T BELIEVE HE WANTED TO BECAUSE, HE HAS NEVER REALLY HAD ANY ISSUES WITH IT OVER THE YEARS. THE NURSE STATED THAT THE HP HAS BEEN PERFORMING THERAPY FINE AND HAS HAD NO ADVERSE REACTIONS DUE TO THE HC CHANGING THE CYCLES.

    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 50 YR