BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1423500-2011-11984

    MDR report key: 2241825 · Received September 9, 2011

    Report

    Report Number
    1423500-2011-11984
    Event Type
    Malfunction
    Date Received
    September 9, 2011
    Date of Event
    August 19, 2011
    Report Date
    August 20, 2011
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) THIS COMPLAINT FOR A SYSTEM ERROR (SE) 2240 (AIR IN SET) WAS CONFIRMED. AS PER THE COMPLAINT INFORMATION THE CAUSE OF THE SE 2240 WAS DUE TO THE PATIENT DISCONNECTED AND RECONNECTED DURING THERAPY. THE CAUSE IS DETERMINED TO BE USE ERROR. THE LABEL REVIEW FOUND THE LABELING ADEQUATE FOR THE POTENTIAL USE ERROR IN THIS COMPLAINT. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. ADDITIONAL INVESTIGATION IS BEING CONDUCTED THROUGH CAPA (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). A 510K NUMBER WILL NOT BE PROVIDED IN THE EMDR, BECAUSE THE PRODUCT AND LOT NUMBER IS UNKNOWN. THE SAMPLE IS NOT AVAILABLE. 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

    THE CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER TO REPORT A SYSTEM ERROR (SE) 2240 WHICH OCCURRED ON HOME CHOICE (HC) ON DURING USE DURING DRAIN 1. THE HOME PATIENT (HP) STATED THAT SHE HAD DISCONNECTED DURING DRAIN 1 AND THEN RECONNECTED. THE BAXTER TECHNICAL REPRESENTATIVE (TSR) HAD THE HP CYCLE POWER AND THE HC ALARMED SE 2367. THE TSR HAD THE HP CYCLE AGAIN AND THE ALARMS CLEARED. THE TSR REVIEWED PROPER PROCEDURES. THE TSR EXPLAINED THE HP TO START OVER WITH NEW SUPPLIES. THERE WAS PATIENT INVOLVEMENT. THERE WAS 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 FKX BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 HOMECHOICE