BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2120981 · Received June 13, 2011

    Report

    Report Number
    1423500-2011-07499
    Event Type
    Malfunction
    Date Received
    June 13, 2011
    Date of Event
    December 26, 2010
    Report Date
    December 26, 2010
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).THE SAMPLE IS NOT AVAILABLE FOR EVALUATION. A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF BAXTER'S INVESTIGATION, OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING A CHECK SUPPLY LINE ALARM THAT APPEARED ON THE HOMECHOICE (HC) UNIT DISPLAY. THIS EVENT OCCURRED DURING PATIENT USE DURING FILL 3/4. THE HOME PATIENT (HP) HAD AN UNKNOWN ALARM DURING PRIMING AND CHANGED CASSETTE BUT RE-SPIKED SUPPLY BAGS; NO SOLUTION IN HEATER BAG LAST FILL BAG HAS SOLUTION. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED ABOUT NOT RE-SPIKING SUPPLY BAGS. THE TSR ADVISED TO LET THE REGISTERED NURSE (RN) KNOW HE RE-SPIKED SUPPLY BAGS. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION 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 HOMECHOICE