BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    MDR report key: 2141644 · Received June 27, 2011

    Report

    Report Number
    1423500-2011-08404
    Event Type
    Malfunction
    Date Received
    June 27, 2011
    Date of Event
    June 3, 2011
    Report Date
    June 3, 2011
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE IS NOT AVAILABLE, THEREFORE, BAXTER CANNOT DETERMINE THE ROOT CAUSE. SINCE THE LOT NUMBER IS UNKNOWN A BATCH REVIEW WILL NOT BE PERFORMED. A 510K NUMBER CANNOT BE PROVIDED IN THIS REPORT BECAUSE THE PRODUCT CODE IS UNKNOWN.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR THE SYSTEM ERROR 2240 (AIR IN LINE) WAS NOT CONFIRMED. A ROOT CAUSE OF THE COMPLAINT WAS NOT DETERMINED. SIMILAR REPORTS HAVE BEEN RECEIVED BY BAXTER FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BAXTER (B)(4) TO THE BAXTER TECHNICAL SERVICES THAT THEY RECEIVED A SYSTEM ERROR 2240 (AIR IN LINE) ALARM ON THE HOMECHOICE. THE HOME PATIENT (HP) STATED HE IS STILL CONNECTED TO THE MACHINE. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) HAD THE HP CYCLE POWER AND DISCONNECT TO REMOVE THE CASSETTE AND DISCARD SUPPLIES. THE TSR EXPLAINED THE ALARM AND ADVISED TO CONTACT NURSE ABOUT MISSED THERAPY. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 HOMECHOICE