BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CADENCE

    MDR report key: 1242124 · Received November 25, 2008

    Report

    Report Number
    2031642-2008-00232
    Event Type
    Injury
    Date Received
    November 25, 2008
    Date of Event
    November 4, 2008
    Report Date
    November 4, 2008
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    BTO
    PMA / PMN Number
    K050379
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED WHILE PREPARING TO REMOVE THE PATIENT FROM THE CADENCE TRIAL AND PLACING HIM BACK ON THE VENTILATOR, THE CATHETER COULD NOT BE REMOVED FROM THE PATIENT'S TRACHEOSTOMY TUBE. AFTER SEVERAL UNSUCCESSFUL ATTEMPTS TO REMOVE THE CATHETER, THE TRACHEOSTOMY TUBE HAD TO BE REMOVED AND REPLACED WITH A NEW ONE. AFTER REMOVING THE TRACHEOSTOMY TUBE, IT WAS FOUND THAT THE CATHETER WAS LODGED IN THE FENESTRATION OF THE REMOVED TRACHEOSTOMY TUBE. PHOTOS WERE TAKEN OF THE TRACHEOSTOMY TUBE AND CATHETER, AND PROVIDED TO THE MANUFACTURER FOR EVALUATION AND ANALYSIS OF THE CATHETER AND TUBE AS REPORTED. IT WAS DETERMINED THAT THE TRACHEOSTOMY TUBE IN USE IN THE PATIENT DURING THE REPORTED EVENT WAS A #8 SHILEY LOW PRESSURE FENESTRATED TUBE, AND NOT THE APPROVED FOR USE #8 SHILEY DFEN FENESTRATED TUBE. THE #8 SHILEY LOW PRESSURE FENESTRATED TUBE HAS ONLY 1 LARGE FENESTRATION IN THE TUBE, WHILE THE APPROVED FOR USE #8 SHILEY DFEN FENESTRATED TUBE HAS 4 SMALL FENESTRATIONS IN THE TUBE. THE EVENT WAS NOT DUE TO A MALFUNCTION OF THE CADENCE CATHETER, BUT RATHER DUE TO THE USE OF THE NON-APPROVED TRACHEOSTOMY TUBE WITH THE LARGE FENESTRATION. THIS IS REPORTED DUE TO AN ADVERSE EVENT AS A RESULT OF THE USER'S FAILURE TO FOLLOW INSTRUCTIONS FOR PROPER TRACHEOSTOMY TUBE USAGE, REQUIRING INTERVENTION OF REPLACING THE TRACHEOSTOMY TUBE TO PREVENT PERMANENT IMPAIRMENT/DAMAGE . THERE WAS NO HARM OR PERMANENT IMPAIRMENT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CADENCE TRANSTRACHEAL CONTINUOUS FLOW CATHETER BTO RESPIRONICS CALIFORNIA, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention