The customer reported that oxygen could be delivered to the patient through the melker emergency cuffed cricothyrotomy catheter, but it could not be removed through the device.The aperture of the catheter was reportedly so small that ventilation could not be achieved, although oxygenation did occur because the air could be forced in.Auto-peep (positive end expiratory pressure) resultantly developed.The patient was taken back to the or to exchange the device emergently for a trach, but ultimately the patient expired.The manufacturer global product manager has attempted to gain additional information on 16mar2018 and was redirected to the user facility risk management department.The manufacturer global product manager was able to speak with the nurse present for the procedure on 19mar2018, she did not provide additional information but has indicated she would have the physician return the manufacturer's call.The customer has indicated that they are unwilling to provide patient-related information.The device is reportedly unavailable for return and evaluation.
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Investigation - evaluation: a review of the device history record, manufacturing instructions, quality control, and specifications of the device was conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.However, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.A review of the device history record shows no nonconforming events which could contribute to this failure mode.It should be noted there were no other reported complaints for this lot number.Based on the information provided, no product returned and the results of our investigation, a definitive root cause could not be determined.We will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.
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