BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    MDR report key: 2011656 · Received March 9, 2011

    Report

    Report Number
    1423500-2011-02924
    Event Type
    Malfunction
    Date Received
    March 9, 2011
    Date of Event
    February 12, 2011
    Report Date
    February 12, 2011
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).UPON FURTHER EVALUATION, IT WAS DETERMINED THAT THE PATIENT DISCONNECTED TO USE THE WASHROOM; THIS CAUSED THE SYSTEM ERROR 2240 ALARM. THE PATIENT DID NOT RE-CONNECT, THEREFORE, THERE IS NO RISK OF CONTAMINATION AND OR INFECTION OF THE PATIENT.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING INVESTIGATION BY BAXTER THIS INCIDENT WAS DETERMINED TO BE CAUSED BY USE ERROR AND THERE WAS NO ALLEGATION OF A PRODUCT MALFUNCTION. THEREFORE A BATCH REVIEW AND SAMPLE EVALUATION WILL NOT BE CONDUCTED. SHOULD ANY ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.A 510K NUMBER CANNOT BE PROVIDED IN THIS REPORT BECAUSE THE PRODUCT CODE IS UNKNOWN AT THIS TIME.

    Description of Event or Problem · 1

    BAXTER AUSTRALIA REPORTED THAT A CUSTOMER CONTACTED BAXTER TECHNICAL SERVICES TO REPORT A SYSTEM ERROR 2240 (AIR INSET) ALARM ON THE HOMECHOICE (HC) MACHINE DURING DRAIN 1 OF 5. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ASSISTED THE HOME PATIENT (HP) TO CLEAR THE ERROR AND INFORMED THE HP OF THE ERROR'S MEANING. THE HP WILL CONTINUE WITH MANUALS. THE HP HAD DISCONNECTED TO USE BATHROOM WHICH CAUSED THE ALARM. THERE WAS PATIENT INVOLVEMENT; HOWEVER 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

    Patients

    Seq Age Sex Outcome Treatment
    1 HOMECHOICE