BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PD CYCLER 110 VOLT HOME CHOICEPRO AUTOMATED

    MDR report key: 1891395 · Received November 4, 2010

    Report

    Report Number
    1423500-2010-05261
    Event Type
    Malfunction
    Date Received
    November 4, 2010
    Date of Event
    October 11, 2010
    Report Date
    October 11, 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). DEVICE HAS BEEN RETURNED AND WILL NOW BE EVALUATED. A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF BAXTER'S INVESTIGATION, OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS DEVICE WAS NOT RETURNED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THEN A FOLLOW UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE CAREGIVER STATED THAT THEY HAD THE MACHINE SET UP AND ACCIDENTALLY PRESSED GO PUTTING THE MACHINE INTO INITIAL DRAIN, BUT PATIENT WAS NOT READY TO CONNECT. THE DEVICE WAS RECEIVED OPERATIONAL AND IN GOOD CONDITION. THE DEVICE PASSED THE HOMECHOICE RITE (RETURN INSTRUMENT TEST / EVALUATION), FUNCTIONAL AND ELECTRICAL TESTS AND WAS FUNCTIONING WITHIN SPECIFICATION. HOWEVER, DUE TO ADDITIONAL THERAPIES BEING PERFORMED AND OVERWRITING THE PREVIOUS THERAPY INFORMATION, THERE IS NO DATA AVAILABLE FROM THE EVENT AND THERAPY LOGS. THE ASSIGNABLE CAUSE FOR THE REPORTED INCIDENT DETERMINED TO BE USE ERROR. A LABELING REVIEW OF THE HOMECHOICE APD SYSTEMS PATIENT AT-HOME GUIDE ISSUED WAS FOUND TO BE ADEQUATE FOR THE USE ERROR(S) IN THE COMPLAINT. 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

    THE CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER FOR ASSISTANCE TO END THERAPY, WHICH OCCURRED ON THE HOMECHOICE (HC) DURING USE. CAREGIVER (CG) STATED THEY HAD THE MACHINE SET UP AND ACCIDENTALLY PRESSED GO PUTTING THE MACHINE INTO INITIAL DRAIN, BUT PATIENT WAS NOT READY TO CONNECT. CG STATED HE WAS TRYING TO START OVER WITH NEW SUPPLIES, BUT COULD NOT OPEN THE DOOR. THE BAXTER TECHNICAL SERVICE REPRESENTATIVE (TSR) ASSISTED WITH ENDING THERAPY. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT.

    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