BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE CYCLER-REFURBISHED

    MDR report key: 1040692 · Received May 8, 2008

    Report

    Report Number
    1423500-2008-00324
    Event Type
    Malfunction
    Date Received
    May 8, 2008
    Date of Event
    April 16, 2008
    Report Date
    April 16, 2008
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FKX
    PMA / PMN Number
    K012988
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4): THE CUSTOMER COULD NOT BE REACHED REGARDING SAMPLE RETURN DESPITE MULTIPLE ATTEMPTS BY BAXTER.

    Description of Event or Problem · 1

    A CUSTOMER CONTACT BAXTER'S TECHNICAL SERVICE CENTER REGARDING FEELING OVERFULL DURING DWELL 1. THE HOME PATIENT REFUSED TO GO TO DRAIN TO DRAIN EVERYTHING OUT. HOME PATIENT DECIDED TO STAY IN THE DWELL. NO FURTHER INFO REGARDING THIS EVENT COULD BE OBTAINED DESPITE MULTIPLE ATTEMPTS BY BAXTER. NO PT INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOMECHOICE CYCLER-REFURBISHED 78FKX FKX BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1