BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED PD SET W/CASSETTE4 PRONG

    MDR report key: 1930923 · Received December 16, 2010

    Report

    Report Number
    1423500-2010-06981
    Event Type
    Malfunction
    Date Received
    December 16, 2010
    Date of Event
    November 25, 2010
    Report Date
    November 25, 2010
    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). THE SAMPLE WAS DISCARDED. SHOULD ANY ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. THE LOT NUMBER WAS NOT PROVIDED; THEREFORE A BATCH REVIEW CANNOT BE CONDUCTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTED CONDITION COULD NOT BE CONFIRMED IN THE LAB DUE TO A LACK OF SAMPLE. THE ROOT CAUSE WAS NOT DETERMINED. REVIEW FOUND THE LABELING ADEQUATE FOR THE USE ERROR IN THE COMPLAINT. SIMILAR REPORTS HAVE BEEN RECEIVED BY BAXTER FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    A HOME PATIENT (HP) CONTACTED (B)(4) REQUESTING ASSISTANCE WITH SET UP OF THE HOME CHOICE (HC) MACHINE. THE HP STATED THAT HE HAD CONTAMINATED A BAG WHILE TRYING TO CONNECT IT AND WANTED TO KNOW HOW TO START OVER. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) HAD THE HP CYCLER POWER TO GET BACK TO SETUP AND START OVER WITH NEW SUPPLIES. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED. (B)(4) CONTACTED THE HOME PATIENT (HP) ON (B)(6) 2010 REGARDING THE REPORTED PROBLEM. THE HP HAS CONTINUED THERAPY NO INJURY OR MEDICAL INTERVENTION WAS REPORTED AS A RESULT OF THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOMATED PD SET W/CASSETTE4 PRONG SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR PD CYCLER