BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    MDR report key: 2070637 · Received April 27, 2011

    Report

    Report Number
    1423500-2011-05083
    Event Type
    Malfunction
    Date Received
    April 27, 2011
    Date of Event
    April 2, 2011
    Report Date
    April 2, 2011
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A REPORTED ISSUE OF LOW DRAIN VOLUME ALARM DURING INITIAL DRAIN WITH PATIENT NOT CONNECTED WAS CONFIRMED. THE CAUSE WAS UNDETERMINED. A SERVICE HISTORY REVIEW AND DEVICE HISTORY REVIEW WERE PERFORMED AND REVEALED NO EVENTS RELATED TO THIS DIFFICULTY. THIS ISSUE IS BEING INVESTIGATED THROUGH CAPA. A 510K NUMBER WILL NOT BE PROVIDED IN THE EMDR AS THIS PRODUCT IS MANUFACTURED FOR DISTRIBUTION OUTSIDE OF THE U.S. AND DOES NOT HAVE A 510K NUMBER. HOWEVER, IT IS BEING REPORTED BECAUSE IT IS THE SAME OR SIMILAR TO THE PRODUCT DISTRIBUTED WITHIN THE U.S.

    Additional Manufacturer Narrative · 1

    (B)(4). A 510K NUMBER CANNOT BE PROVIDED IN THIS REPORT BECAUSE THE PRODUCT CODE IS UNKNOWN AT THIS TIME.

    Description of Event or Problem · 1

    REPORTEDLY ON (B)(6) 2011, THE HOMECHOICE MACHINE SOUNDED A LOW DRAIN VOLUME ALARM DURING THE INITIAL DRAIN. THE PATIENT WAS NOT CONNECTED TO THE MACHINE. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ASSISTED THE CAREGIVER (CG) TO END THE THERAPY. THE CG SAID HE HAD DISCONNECTED THE PATIENT. THE TSR INFORMED TO START OVER USING NEW SUPPLIES. NO CLINICAL CONSEQUENCES FOR THE PATIENT WERE REPORTED. THERE WAS NO PATIENT INVOLVEMENT. 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