BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    MDR report key: 2143433 · Received June 29, 2011

    Report

    Report Number
    1423500-2011-08492
    Event Type
    Malfunction
    Date Received
    June 29, 2011
    Date of Event
    April 24, 2011
    Report Date
    April 24, 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). SINCE THE PRODUCT CODE IS UNKNOWN, THERE WILL NOT BE A 510K NUMBER PROVIDED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW UP MDR WILL BE SENT.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR A CHECK PATIENT LINE ALARM WAS NOT CONFIRMED AND THE CAUSE WAS NOT IDENTIFIED. THE SAMPLE WAS NOT RETURNED FOR EVALUATION. THE LOT NUMBER WAS NOT PROVIDED; THEREFORE A BATCH REVIEW WAS NOT CONDUCTED. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    Description of Event or Problem · 1

    A HOME PATIENT (HP) REPORTED TO BAXTER'S AFTER HOURS CALL SERVICE THAT THE HOMECHOICE MACHINE SOUNDED A CHECK PATIENT LINE ALARM DURING I-DRAIN. THE PATIENT WAS CONNECTED TO THE MACHINE AND STATED THAT HE SAW AIR IN THE PATIENT LINE. THE HP REQUESTED TO START OVER WITH NEW SUPPLIES. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) REVIEWED THE DRAIN VOLUME (DV) = 18 ML. THE ASSISTED THE HP WITH ENDING THE THERAPY AND GETTING THE SET OUT. NO CLINICAL CONSEQUENCES FOR THE PATIENT WERE REPORTED.

    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