BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLOTRAC SENSOR

    MDR report key: 3230307 · Received July 16, 2013

    Report

    Report Number
    2015691-2013-20620
    Event Type
    Injury
    Date Received
    July 16, 2013
    Date of Event
    June 22, 2013
    Report Date
    June 22, 2013
    Manufacturer
    EDWARDS LIFESCIENCES DR
    Product Code
    DRS
    PMA / PMN Number
    K043065
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED; IT WAS DISCARDED AT THE HOSPITAL. NO DEVICE MALFUNCTION IS ALLEGED OR SUSPECTED. THE FLOTRAC INSTRUCTIONS FOR USE INSTRUCT THE USER TO CONNECT THE SENSOR CABLE WITH THE RED SHIELD TO THE REUSABLE CABLE APPROPRIATE FOR THE PRESSURE MONITOR, AND TO CONNECT THE SENSOR CABLE WITH THE GREEN SHIELD TO THE EDWARDS¿ FLOTRAC CONNECTING CABLE. NO DEFICIENCIES ARE NOTED IN THE LABELING OR INSTRUCTIONS. REVIEW OF THE AVAILABLE INFORMATION INDICATES THAT THE CAUSE OF THE EVENT IS USER ERROR. NO ACTIONS WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    THE REPORT INDICATED THAT THE FLOTRAC MONITORING SYSTEM WAS SET UP INCORRECTLY, WHICH RESULTED IN 2 ARTERIAL LINE TRACES INSTEAD OF ONE A-LINE AND ONE CVP-LINE. IT WAS ASSUMED THAT THE LINE WAS PLACED IN THE CAROTID ARTERY INSTEAD OF THE JUGULAR VEIN AND THE PATIENT WAS TAKEN BACK TO SURGERY FOR LINE REVISION. AS REPORTED: THE PATIENT HAD INITIALLY COME BACK FROM THEATRE (OR) AFTER HAVING SURGERY AND THE FLOTRAC HAD BEEN SET UP IN THEATRE AND WAS ATTACHED TO THE RADIAL ARTERY AND USED WITH THE EV1000 WHILST IN THEATRE. A CVP LINE HAD BEEN INSERTED BUT WAS NOT CONNECTED TO AN EDWARDS CVP TRANSDUCER, AS THE CASE APPEARED TO GO VERY QUICK AND THE DECISION WAS TO CONNECT UP WHEN THEY GOT TO THE ICU. ON ADMISSION TO THE ICU AND CONNECTING THE PRESSURE CABLES TO THE BEDSIDE MONITOR THE STAFF NOTICED THEY HAD TWO ARTERIAL PRESSURE TRACES ON THE PHILIPS BEDSIDE MONITOR. ONE WAS SUPPOSED TO BE THE ARTERIAL PRESSURE FOR THE BLOOD PRESSURE AND THE OTHER A CVP TRACE AND READING BUT THEY WERE GETTING TWO ARTERIAL TRACES. THE STAFF APPEARED TO HAVE CONNECTED THE PRESSURE CABLE FOR THE BP TO THE RED PORT ON THE FLOTRAC BUT ALSO CONNECTED THE CVP TRANSDUCER TO THE GREEN PORT ON THE FLOTRAC SENSOR GIVING THEM TWO ARTERIAL PRESSURE TRACES. THE PATIENT WAS SENT BACK TO THEATRE FOR NECK DISSECTION SURGERY THINKING THE CVP LINE WAS IN AN ARTERY. THE DOCTOR DISCOVERED THAT CVP LINE WAS IN THE CORRECT VEIN THEN IN THEATRE THEY DISCOVERED THE TWO PRESSURE CABLES FOR BOTH ARTERIAL AND CVP READINGS WERE CONNECTED TO THE RED AND GREEN PORTS ON THE FLOTRAC SENSOR. NO LASTING INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328642 FLOTRAC SENSOR FLOTRAC SENSOR DRS EDWARDS LIFESCIENCES DR MHD8R

    Patients

    Seq Age Sex Outcome Treatment
    1