BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMED GEMINI

    MDR report key: 537640 · Received June 8, 2004

    Report

    Report Number
    MW1032473
    Event Type
    Malfunction
    Date Received
    June 8, 2004
    Date of Event
    January 1, 2003
    Report Date
    June 8, 2004
    Manufacturer
    ALARIS MEDICAL SYSTEMS, INC.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    ADD'L INFO REC'D FROM MFR 9/24/04: BACKGROUND INFO: THIS CUSTOMER DID NOT DIRECTLY REPORT THIS ISSUE TO THE MANUFACTURER, ALARIS MEDICAL SYSTEMS, INC. MFR BECAME AWARE OF THE REPORTED EVENT VIA INTERNET LISTSERV DISCUSSION. THE CUSTOMER WAS CONTACTED FOR ADD'L INFO AND TO OFFER ASSISTANCE IN DEVICE SERVICE OR EVALUATION IF NEEDED. INFO ABOUT THE DEVICE'S RECOMMENDED CLEANING PROCEDURE WAS PROVIDED TO THE CUSTOMER, INCLUDING INFO FROM THE DIRECTIONS FOR USE MANUAL FOR THE DEVICE. THE EXPECTED FREQUENCY OF THIS PART FAILING AS A RESULT OF CLEANING PROCEDURES IS ZERO AS LONG AS THE DIRECTIONS FOR USE FOR CLEANING ARE FOLLOWED. ALARIS MEDICAL SYSTEMS, INC. HAS REPORTS FROM 2 CUSTOMERS WITH BROKEN DOOR SEARS RELATED TO DAMAGE FROM THE USE OF IMPROPER CLEANING SOLUTIONS. BOTH REPORTS ORIGINATED FROM THE SAME LISTSERV DISCUSSION, BOTH CUSTOMERS WERE CONTACTED BY ALARIS, NO FURTHER INFO WAS OBTAINED FROM EITHER CUSTOMER. BASED ON A REVIEW OF COMPLAINT HISTORY THERE HAVE BEEN NO FURTHER REPORTS FROM CUSTOMERS TO ALARIS OF DOOR SEAR BREAKAGE FROM UNAPPROVED CLEANING AGENTS FOR ANY MODEL OF THE GEMINI PUMP.

    Description of Event or Problem · 1

    TO PROVIDE INHERENT FREE-FLOW PROTECTION, THESE INFUSION PUMPS EMPLOY A PLASTIC "SEAR" TO CLOSE A SET-BASED SLIDE CLAMP WHEN THE DOOR IS OPENED TO ACCESS OR REMOVE THE IV TUBING SET. IN 2003 FACILITY WAS EXPERIENCING SIGNIFICANT FAILURE OF THE PLASTIC "SEAR" AT THE FACILITY. WITH THE HELP OF ALARIS MEDICAL SYSTEMS, FACILITY DETERMINED THAT THE PREMATURE FAILURE WAS CAUSED BY THE USE OF AN IMPROPER CLEANING PROCEDURE AND AN UNAPPROVED CLEANING AGENT WHEN CLEANING THE IV PUMPS. THE CLEANING AGENT VIREX WAS SOFTENING AND WEAKENING THE PLASTIC "SEAR". IN 2003 MEDICAL AND SURGICAL NURSING STAFF, HOUSEKEEPING, AND CENTRAL STERILE STAFF WERE TRAINED ON PROPER IV PUMP CLEANING PROCEDURE AND USE OF APPROVED CLEANING AGENTS. STAFF ALSO TRAINED TO WATCH FOR AND REMOVE FROM SERVICE ANY BROKEN IV PUMPS. IN JANUARY, 2004 FACILITY ATTACHED TAGS TO THE IV PUMPS WITH THE MFR'S CLEANING INSTRUCTIONS. THIRTEEN "SEAR" FAILURES WERE FOUND BETWEEN 04/03 AND 10/03, SIX DURING BIOMED INSPECTIONS. SINCE STAFF TRAINING IN OCTOBER 2003, FOUR IV PUMPS HAVE EXPERIENCED FAILURE OF THE FREE-FLOW PROTECTION "SEAR", ONLY ONE SINCE 02/04. ALL RECENT FAILURES WERE FOUND AND REPORTED BY STAFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMED GEMINI VOLUMETRIC INFUSION PUMP/CONTROLLER FRN ALARIS MEDICAL SYSTEMS, INC. 1310B NA
    2 IMED GEMINI VOLUMETRIC INFUSION PUMP/CONTROLLER FRN ALARIS MEDICAL SYSTEMS 1325D NA

    Patients

    Seq Age Sex Outcome Treatment
    1 *