BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CYCLER 220 VOLT HOMECHOICE PROAUTOMATED PD

    MDR report key: 1971652 · Received January 27, 2011

    Report

    Report Number
    1423500-2011-01102
    Event Type
    Malfunction
    Date Received
    January 27, 2011
    Date of Event
    January 10, 2011
    Report Date
    January 10, 2011
    Manufacturer
    BAXTER HEALTHCARE - TAMPA
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ACTUAL DEVICE WAS RECEIVED AND EVALUATED. THE ISSUE WASN'T CONFIRMED. ELECTRICAL SAFETY TESTS WERE PERFORMED AND WERE PASSED. DEVICE WAS FULLY TESTED AND CALIBRATED DURING EVALUATION. THE ROOT OF COMPLAINT WASN'T DETERMINED. DEVICE WORKS LIKE INTENDED. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RECEIVED BY BAXTER, AND THE EVALUATION HAS NOT YET BEEN COMPLETED. A FOLLOW-UP MDR WILL BE SUBMITTED UPON COMPLETION OF THE EVALUATION OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.THIS DEVICE IS MANUFACTURED FOR DISTRIBUTION OUTSIDE OF THE UNITED STATES (US); THEREFORE, IT DOES NOT HAVE A US 510K NUMBER. HOWEVER, THIS MDR IS BEING SUBMITTED BECAUSE IT IS THE SAME AS OR SIMILAR TO A PRODUCT DISTRIBUTED WITHIN THE US.

    Description of Event or Problem · 1

    AN EMPLOYEE REPORTED TO BAXTER (B)(4) THAT THEY RECEIVED A REPORT FROM A HOME PATIENT (HP) THAT THE HP DURING SETUP OF HIS HOMECHOICE MACHINE RECEIVED A SHOCK AND WANTED THE DEVICE SWAPPED. THERE WAS PATIENT INVOLVEMENT, BUT NO INJURY OR MEDICAL INTERVENTION WAS REPORTED AS A RESULT OF THIS INCIDENT. THE DEVICE WAS SWAPPED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CYCLER 220 VOLT HOMECHOICE PROAUTOMATED PD SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - TAMPA

    Patients

    Seq Age Sex Outcome Treatment
    1