BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET W/CASSETTE 4-PRONG

    MDR report key: 776999 · Received September 25, 2006

    Report

    Report Number
    1423500-2006-01054
    Event Type
    Malfunction
    Date Received
    September 25, 2006
    Date of Event
    September 17, 2006
    Report Date
    September 17, 2006
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    BAXTER'S PRODUCT SURVEILLANCE DEPARTMENT REVIEWED PROPER PROCEDURE WITH THE HOME PATIENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING FOR ASSISTANCE. THE HOME PATIENT DISCONNECTED THE HEATER BAG AND PUT THE FINAL BAG ON THE HEATER LINE. A FOLLOW-UP CALL WAS PLACED TO THE HOME PATIENT ON SEPTEMBER 25, 2006. THE HOME PATIENT STATED HE MIXED-UP THE LINES AND REALIZED HIS MISTAKE WHEN HE SPIKE A NEW SUPPLY BAG WITH THE HEATER LINE. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS ASSOCIATED WITH THIS REPORT PER THE HOME PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOMECHOICE AUTOMATED PD SET W/CASSETTE 4-PRONG HOMECHOICE CASSETTE FKX BAXTER HEALTHCARE CORPORATION NA NA01

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR DIANEAL LOW CALCIUM SOLUTION (STRENGTH UNKNOWN)| HOMECHOICE AUTOMATED PD SYSTEM 115 VOLT| CAPD TRANSFER SET