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It was reported by a baxter account executive (ae) that during a volara product demonstration at an outpatient clinic, a nurse who was in attendance used the device and experienced a seizure.There was no allegation of a device malfunction.The following additional information was obtained from the baxter ae.The nurse in this event had a medical history of asthma and seizures and was under the care of neurology.At the time of the reported event, the nurse stated that she wanted to try the volara because of her asthma history.The device was on the low setting and the nurse stated she could ¿feel her lungs were working¿ (clarified as a positive effect related to her asthma).After a couple of minutes on the low setting, the nurse requested to increase the setting to medium.While on the medium setting in the oscillating phase, the ae noticed the nurse was tugging on the tubing and her body appeared to be stiffening.The employees in the room (nurses and doctors) who knew the nurse¿s medical history realized she was having a seizure and the nurse was assisted to the floor while staff simultaneously called 911.The ae stated the nurse was noted to have secretions in her mouth and was turned on her side and 15l oxygen was administered via non-rebreather mask.The nurse's spo2 was 97-100% throughout the event and her heart rate was elevated in the upper 100's.The nurse was alert and oriented by the time emergency medical services arrived and she called her mom prior to being transported to the hospital.The nurse was monitored in the emergency room (er) for 3 hours before being discharged home with instructions to follow up with neurology.No treatment was provided while in the er.The nurse was seen by neurology, started on medication, and was reported to be on medical leave until june.It was reported by a colleague to the ae that the nurse has had increased seizure activity and was recently cleared to return to work by her neurologist with no medication.It was also reported that the nurse had additionally been experiencing some personal stressors prior to the onset of the seizure that day.The volara¿ system is intended for the mobilization of secretions, lung expansion therapy, the treatment and prevention of pulmonary atelectasis, and has the ability to provide supplemental oxygen when used with an oxygen supply.A review of absolute and relative contraindications in the device instructions for use does not list seizure disorder as a contraindication for use.A seizure is a sudden, uncontrolled electrical disturbance in the brain.It can cause changes in your behavior, movements, or feelings, and in levels of consciousness.It is noted the nurse in this event had a history of untreated seizures and recent increased seizure activity; however, the volara device cannot be excluded as a contributing factor to the event.The nurse required medical intervention to preclude permanent impairment of a body function or permanent damage to a body structure, concluding a serious injury occurred.At this time, an inspection of the device is pending, and a malfunction cannot be ruled out.Should additional information become available, the complaint will be reassessed.Additional information, following completion of the investigation will be included in the final report.
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The volara device is intended to be used with patients over two years of age, for the mobilization of secretions, lung expansion therapy, the treatment and prevention of pulmonary atelectasis, and has the ability to provide supplemental oxygen when used with an oxygen supply.Inspection by a hillrom technician found the device to be functioning as designed.However as the nurse required medical intervention to preclude permanent impairment of a body function or permanent damage to a body structure it can be concluded that a serious injury occurred.Based on this information, no further action is required.
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