BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOWTRON EXCEL TRIO PUMP

    MDR report key: 2328160 · Received October 21, 2011

    Report

    Report Number
    1000381138-2011-00030
    Event Type
    Malfunction
    Date Received
    October 21, 2011
    Date of Event
    September 1, 2011
    Report Date
    September 22, 2011
    Manufacturer
    ARJOHUNTLEIGH
    Product Code
    JOW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED UNDER (B)(4) BY ARJOHUNTLEIGH ON BEHALF OF THE MANUFACTURER ARJOHUNTLEIGH, A BRANCH OF ARJO (B)(4). THE EVAL OF THE DEVICE TO DATE HAS BEEN CARRIED OUT BY A REP OF THE MANUFACTURER'S SALES AND SERVICE UNIT SUBSIDIARY DIVISIONS, NOT A DIRECT EMPLOYEE OF THE MANUFACTURER. THE INFO CONTAINED IN THIS INITIAL REPORT IS BASED UPON THE INFO PROVIDED TO THE MANUFACTURER. ADDITIONAL INFO WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE MANUFACTURER'S INVESTIGATION.

    Description of Event or Problem · 1

    CONTACT STATES THAT THE FLOWTRON TRIO WAS IN USE DURING A SURGICAL PROCEDURE WITH PLACEMENT ON THE FLOOR UNDERNEATH THE SURGICAL TABLE. AN OPERATING ROOM PERSONNEL (SCRUB TECH) ACCIDENTALLY HIT THE ON/OFF SWITCH WITH THEIR FOOT WHICH CAUSED THE SWITCH TO POP OFF CAUSING SPARKS FROM THE PUMP AS THE SURGICAL PROCEDURE WAS IN PROGRESS. THE TRIO SYSTEM WAS TAKEN OUT OF SERVICE IMMEDIATELY AND REPLACED WITH ANOTHER TRIO SYSTEM DURING COMPLETION OF THE PROCEDURE. NO PT OR STAFF INJURIES WERE INCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLOWTRON EXCEL TRIO PUMP JOW ARJOHUNTLEIGH 512003

    Patients

    Seq Age Sex Outcome Treatment
    1 Other