BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PD CYCLER 110 VOLT HOME CHOICEPRO AUTOMATED

    MDR report key: 1953264 · Received January 7, 2011

    Report

    Report Number
    1423500-2011-00290
    Event Type
    Malfunction
    Date Received
    January 7, 2011
    Date of Event
    December 15, 2010
    Report Date
    December 15, 2010
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K053512
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RECEIVED, AND THE EVALUATION IS IN PROCESS. A FOLLOW-UP MDR WILL BE SUBMITTED UPON COMPLETION OF THE EVALUATION OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE PASSED BOTH THE HOMECHOICE RETURN INSTRUMENT TEST / EVALUATION (RITE) ELECTRICAL AND FUNCTIONAL TESTS AND WAS DETERMINED TO MEET PERFORMANCE SPECIFICATIONS. THE REPORTED DIFFICULTY OF A LOOSE POWER CORD IN THE BACK OF THE DEVICE WAS NEITHER CONFIRMED IN THE DEVICE LOGS NOR DUPLICATED DURING EVALUATION. THE CAUSE OF THE LOOSE POWER CORD WAS UNDETERMINED. A REVIEW OF THE PREVIOUS SERVICE RECORD SHOWS THE DEVICE PASSED ALL REQUIRED TESTS AND CALIBRATIONS PRIOR TO ITS RELEASE FROM THE (B)(4) FACILITY AND NO ISSUES WERE IDENTIFIED THAT MAY HAVE CONTRIBUTED TO THE LOOSE POWER CORD. 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 NURSE CONTACTED BAXTER'S TECHNICAL SERVICE CENTER TO REPORT A CHECK SUPPLY LINE ALARM ON A HOME CHOICE (HC) TRAINING DEVICE DURING PRIME. THE REGISTERED NURSE (RN) STATED THAT THE POWER CORD IN THE BACK OF THE HC WAS VERY LOOSE AND SHE HAD TO WIGGLE IT FOR THE HC TO POWER UP. THIS IS A REPORTABLE EVENT. THE TECHNICAL SERVICE REPRESENTATIVE INITIATED A SWAP OF THE MACHINE DUE TO A POWER CORD ISSUE. THERE WAS NO PATIENT INVOLVEMENT BECAUSE THIS WAS A TRAINING DEVICE. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS 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