BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2073576 · Received May 2, 2011

    Report

    Report Number
    1423500-2011-05259
    Event Type
    Malfunction
    Date Received
    May 2, 2011
    Date of Event
    April 9, 2011
    Report Date
    April 9, 2011
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). UPON FURTHER FOLLOW UP, THIS REPORT SHOULD BE AGAINS THE HOMECHOICE UNIT, NOT THE CASSETTE.

    Additional Manufacturer Narrative · 1

    (B)(4). A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF BAXTER'S INVESTIGATION, OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS IS A CORRECTION TO THE INITIAL AND FOLLOW UP 001 MDRS.UPON FURTHER REVIEW OF THIS REPORT, IT WAS REVEALED THAT THE PATIENT WAS NOT CONNECTED AT THE TIME OF THIS INCIDENT; THEREFORE, THIS DOES NOT REPRESENT A DEVICE FAILURE MODE, MALFUNCTION AND/OR USE ERROR THAT COULD CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY WERE IT TO RECUR.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING ASSISTANCE TO RE-PRIME THE PATIENT LINE. THE HOME PATIENT (HP) STATED THAT SHE WAS NOT CONNECTED BUT THE HOMECHOICE (HC) WAS IN INITIAL DRAIN. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) INFORMED THE HP TO END THE THERAPY AND START SET UP OVER AGAIN. THE NO PATIENT INJURY OR MEDICAL INTERVENTION WAS INDICATED AT THE TIME OF THE INITIAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR HOMECHOICE CYCLER