BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2232276 · Received September 2, 2011

    Report

    Report Number
    1423500-2011-11615
    Event Type
    Malfunction
    Date Received
    September 2, 2011
    Date of Event
    August 14, 2011
    Report Date
    August 14, 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 REPORT OF A CHECK PATIENT LINE ALARM WAS CONFIRMED AND THE CAUSE WAS IDENTIFIED AS FIBRIN BLOCKAGE BASED ON THE INFORMATION PROVIDED BY THE PATIENT. ADDITIONAL INVESTIGATION IS IN PROGRESS THROUGH (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE IS NOT AVAILABLE AND 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

    DURING ASSISTANCE WITH A CHECK PATIENT LINE ALARM ON THE HOME CHOICE (HC), THIS OCCURRED ON THE HOMECHOICE (HC) DURING USE, DURING INITIAL DRAIN, THE PATIENT FOUND AIR WITHIN THE LINE. THE PATIENT WAS TOLD BY THE BAXTER TECHNICAL SERVICE REPRESENTATIVE (TSR) TO END THERAPY AND TO CONTACT THEIR NURSE. DURING A FOLLOW-UP WITH THE HOME PATIENT (HP) REGARDING THE REPORTED PROBLEM, THE HP STATED THAT THEY DID END THERAPY FOR THE EVENING, AND THEN CONTACTED THEIR NURSE. THEIR NURSE TOLD THEM TO FINISH THERAPY IN THE MORNING USING MANUAL SUPPLIES, THE HP DID SO AND WAS ABLE TO RESUME WITHOUT FURTHER PROBLEMS. THE HP STATED THERAPY HAS BEEN GOING FINE SINCE. THERE WAS PATIENT INVOLVEMENT BUT 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 66 YR HOMECHOICE