BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PD CYCLER 110 VOLT HOME CHOICEPRO AUTOMATED

    MDR report key: 1863776 · Received October 11, 2010

    Report

    Report Number
    1423500-2010-04283
    Event Type
    Malfunction
    Date Received
    October 11, 2010
    Date of Event
    September 16, 2010
    Report Date
    September 16, 2010
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K053512
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE PRODUCT ANALYSIS LAB (PAL) EVALUATED THE DEVICE. THE MACHINE SYSTEM FAILED RITE (RETURNED INSTRUMENT TEST/EVALUATION) TESTING DUE TO A HEATER BAG TEMPERATURE FAILED PERFORMANCE SPECIFICATION- FLUID DELIVERED WAS OUT OF SPECIFICATION. DURING FURTHER EVALUATION, IT WAS DETERMINED THAT THE FAILURE OCCURRED AT 34 DEGREES CELSIUS. BASED ON THIS INFORMATION, THIS EVENT HAS BEEN DETERMINED TO NOT BE A REPORTABLE MALFUNCTION. A SERVICE HISTORY REVIEW REVEALED NO PREVIOUS SERVICE EVENTS WERE RELATED TO THE RITE FAILURE.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RECEIVED BY BAXTER, HOWEVER THE EVALUATION HAS NOT BEEN COMPLETED. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE DEVICE EVALUATION, OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    DURING EVALUATION OF THE HOMECHOICE (HC) MACHINE DEVICE, THE (B)(4) LABORATORY DETERMINED THAT THE HC MACHINE SYSTEM FAILED RITE (RETURNED INSTRUMENT TEST/EVALUATION) TESTING DUE TO THE FOLLOWING FAILURE: THE HEATER BAG TEMPERATURE FAILED PERFORMANCE SPECIFICATION AS THE FLUID DELIVERED WAS OUT OF SPECIFICATION. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS INDICATED. NO FURTHER INFORMATION WAS PROVIDED.

    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