BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED PD SET W/CASSETTE4 PRONG

    MDR report key: 1971833 · Received January 27, 2011

    Report

    Report Number
    1423500-2011-01121
    Event Type
    Malfunction
    Date Received
    January 27, 2011
    Date of Event
    January 6, 2011
    Report Date
    January 6, 2011
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT IS FOR A REPORT OF AIR IN TUBING. PER THE COMPLAINT INFORMATION, THE HEATER BAG WAS BELOW THE HOMECHOICE MACHINE AND THE SUPPLY BAG WAS ON TOP. THIS SOLUTION BAG ARRANGEMENT PREVENTED PROPER PRIMING OF THE PATIENT LINE SINCE THE PATIENT LINE IS PRIMED FROM FLUID IN THE HEATER BAG BY GRAVITY. THIS COMPLAINT WAS NOT CONFIRMED IN THE LAB DUE TO A LACK OF SAMPLE. PER THE COMPLAINT INFORMATION, THE CAUSE OF THE AIR IN TUBING IS USER ERROR. THIS REVIEW FOUND THE LABELING ADEQUATE FOR THE USER 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.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE IS NOT AVAILABLE. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON THE COMPLETION OF BAXTER'S QUALITY REVIEW.

    Description of Event or Problem · 1

    DURING TROUBLESHOOTING FOR A RELATED REPORT, THE NURSE (RN) REPORTED TO BAXTER'S TECHNICAL SERVICE CENTER THAT SHE SET THE HEAT BAG LOWER THAN THE HOMECHOICE (HC) AND SUPPLY BAG ON TOP. THE NURSE STATED A HOME PATIENT (HP) BYPASSED THE INITIAL DRAIN AND WAS THEN FILLED WITH AIR. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED PROPER SET UP AND ADVISED TO CHECK THE PATIENT LINE BEFORE CONNECTING TO VERIFY THE LINE WAS FILLED. THE TSR WAS NOT ABLE TO GET PATIENT NAME FROM THE NURSE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOMATED PD SET W/CASSETTE4 PRONG SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 HOMECHOICE APD CYCLER