BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE CYCLER-REFURBISHED

    MDR report key: 1853276 · Received October 5, 2010

    Report

    Report Number
    1423500-2010-04048
    Event Type
    Malfunction
    Date Received
    October 5, 2010
    Date of Event
    September 10, 2010
    Report Date
    September 10, 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). THE DEVICE IS NOT AVAILABLE AT THIS TIME. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). UPON FURTHER INVESTIGATION BY BAXTER, THIS EVENT HAS BEEN DETERMINED TO BE NON-REPORTABLE. THE HOMEPATIENT DID NOT INTENTIONALLY BY-PASS THE INITIAL DRAIN THUS THIS DOES NOT REPRESENT A FAILURE MODE, MALFUNCTION AND/OR USE ERROR .

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S GLOBAL TECHNICAL SERVICE CENTER TO DISCUSS CONCERNS WITH THERAPY ON THE HOMECHOICE (HC) DEVICE. THE CAREGIVER (CG) STATED HE STEPPED AWAY FOR AN HOUR AND THINKS THE HC MIGHT HAVE SKIPPED THE INITIAL DRAIN OR THE FIRST FILL BECAUSE THE HC MOVED TO THE DWELL TOO QUICKLY. THE TECHNICAL SERVICE REPRESENTATIVE EXPLAINED TO THE CG THAT THE MACHINE TAKES ABOUT 15 TO 20 MINUTES TO DRAIN THE HOMEPATIENT (HP) AND 15 TO 20 MINUTES TO FILL THE HP. THE TSR THEN ASSISTED THE CG TO PRESS STOP AND THEN DO A MANUAL AND THEN ADVISED THE CG TO CALL THE PERITONEAL DIALYSIS NURSE FOR FURTHER TRAINING ON THE HC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOMECHOICE CYCLER-REFURBISHED SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR