This report was opened to capture the second circuit/valve that failed in (b)(6). patient was on the rt609-855 using the newport ht70+.Upon arrival from a patient procedure, the high pressure alarm kept triggering, the rcp conducted an assessment of the circuit and decided to disconnect the patient for patient safety.While the patient was attended to by the nurse, the rcp determined that there was no flow coming out of the circuit.The rcp attempted to recalibrate the ventilator with the circuit and it failed calibration.The rcp took another rt609-855 circuit setup and attempted calibration and once again it failed.We then changed the exhalation valve on the rt 609-855 circuit, it was at that time that the calibration passed.Patient placed back on the ventilator.Sample of the valve is available.
|
(b)(4).Device evaluation: one (1) sample was received for evaluation at carefusion¿s research and design group in (b)(4).Based on their evaluation, it was concluded that airlife circuit rt609-855 frequently fails the calibration test on the newport medical ht50 and sometimes the ht70.A review of the documentation of internal manufacturing device history records could not be reviewed due to no lot number being reported.At this time, an alternative circuit is being created with a compatible exhalation valve.Carefusion will continue to monitor and trend this issue.
|