BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2180373 · Received July 27, 2011

    Report

    Report Number
    1423500-2011-09759
    Event Type
    Malfunction
    Date Received
    July 27, 2011
    Date of Event
    July 3, 2011
    Report Date
    July 4, 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). THIS COMPLAINT FOR AIR IN TUBING (WITHOUT ALARM) WAS NOT CONFIRMED DUE TO UNAVAILABLE SAMPLE. THE CAUSE WAS THAT THE PATIENT CONNECTED DURING THE PRIMING OF THE DISPOSABLE SET. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED. RENAL QUALITY ENGINEERING, ALONG WITH PLANT QUALITY AND MANUFACTURING PERSONNEL, WILL CONTINUE TO MONITOR THIS PRODUCT LINE FOR TRENDS AND WILL TAKE CORRECTIVE/PREVENTIVE ACTION AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE AVAILABILITY IS UNKNOWN.THE LOT NUMBER IS UNKNOWN. SINCE THE LOT NUMBER IS UNKNOWN, NO BATCH REVIEW WILL BE PERFORMED. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS OBTAINED

    Description of Event or Problem · 1

    THIS REPORT IS TO ADDRESS THE ISSUE OF AIR IN PATIENT LINE. THE CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER TO REPORT A CHECK PATIENT LINE OCCURRED ON HOME CHOICE (HC) DURING USE DURING DRAIN 1 . THE BAXTER TECHNICAL REPRESENTATIVE (TSR) HAD THE HOME PATIENT (HP) CHECK LINE FOR KINKS AND OCCLUSION. THE HP STATED THAT THE LINE WAS FULL OF AIR BUBBLES. INITIAL DRAIN VOLUME (IDV)=3ML. THE TSR ASSISTED THE HP IN ENDING THERAPY AND ADVISED TO START OVER WITH NEW SUPPLIES. THERE WAS PATIENT INVOLVEMENT. 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 62 YR HOMECHOICE