BEUDAMED
    FDA Adverse Event Other Summary report: N

    NEOTREND-L SENSOR

    MDR report key: 330075 · Received April 27, 2001

    Report

    Report Number
    9612233-2001-00009
    Event Type
    Other
    Date Received
    April 27, 2001
    Date of Event
    April 15, 2001
    Report Date
    April 16, 2001
    Manufacturer
    DIAMETRICS MEDICAL, LTD.
    Product Code
    CCE
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    AN UMBILICAL ARTERY CATHETER (UAC) AND UMBILICAL VENUOS CATHETER (UVC) WERE PLACED IN THE PATIENT. THE CATHETERS IN USE WERE NOT MANUFACTURED BY DIAMETRICS MEDICAL LIMITED (DML). A DML NEOTREND-L SENSOR WAS INSERTED AND THEN, FOR REASONS NOT UNDERSTOOD, PARTIALLY WITHDRAWN AND A HEMOSTAT WAS CLAMPED ON THE CATHETER. UPON REMOVAL OF THE HEMOSTAT, THE SENSOR WAS REINTRODUCED DOWN THE CATHETER. THE MONITOR DISPLAYED A SENSOR SEVERELY BENT ERROR CODE, AND THE SENSOR WAS RETRACTED AND PHYSICALLY REMOVED. THE CLINICIAN NOTED THAT THE END OF THE SENSOR APPEARED "FRAYED". THE SENSOR WAS THEN DISCARDED. A SECOND WAS INSERTED. A CHEST RADIOGRAPH WAS TAKEN ON WHICH TWO GOLD MARKERS WERE VISIBLE. ONE WAS IN THE EXPECTED LOCATION, APPROXIMATELY 1.5-2.0CM BEYOND THE TIP OF THE UAC, BUT THE OTHER WAS ADJACENT TO THE RIGHT HEART BORDER. THE DOCTOR SPECULATED THAT THE FIRST SENSOR HAD BEEN INTRODUCED DOWN THE UVC, WHICH WAS AN IDENTICAL CATHETER TO THE UAC. A TIP SEPARATION PROBABLY OCCURRED WHEN THE HEMOSTAT CLAMPED THE CATHETER. WHEN THE DAMAGE SENSOR WAS REINTRODUCED DOWN THE UVC, THE GOLD MARKER, WITH OR WITHOUT THE POLYETHYLENE MICROPOROUS MEMBRANE, PASSED UP THE INFERIOR VENA CAVA, THOUGH THE RIGHT HEART AND INTO THE RIGHT PULMONARY ARTERY. THE DOCTOR STATED THAT NEITHER THE UAC NOR THE UVC WERE LABELED AS TO THEIR VESSEL LOCATION AND THE SAME MODEL ARGYLE CATHETERS WERE USED TO CANNULATE THE VESSELS. IN ADDITION, BOTH THE ARGYLE CATHETER AND THE NEOTREND-L INSTRUCTION LEAFLETS WARN THE USER NOT TO USE CLAMPS IN ASSOCIATION WITH THE DEVICE. IT WAS THE DOCTOR'S OPINION THAT THIS INCIDENT WAS DUE TO "USER ERROR". MEDICAL OPINION IS THAT SURGICAL INTERVENTION IS UNNECESSARY. THE MATERIAL FROM THE SENSOR SHOULD BEGIN TO PERMANENTLY ADHERE TO THE VASCULAR WALL AND BENIGNLY GROW INTO ITS SUPPORTIVE STRUCTURE. DUE TO THIS DECISION BY THE HOSPITAL, DML HAS CONDUCTED A RISK ASSESSMENT ON THE MATERIALS FOR THE LONG-TERM NATURE OF THIS EVENT AND CONCLUDES THAT THE MATERIALS ARE BIOCOMPATIBLE FOR IMPLANTABLE USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    19746 NEOTREND-L SENSOR BLOOD GAS MONITORING SYSTEM CCE DIAMETRICS MEDICAL, LTD. N7004L UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 3 HR Other