The device was received, and evaluation was completed.The event history log review was completed.A visual inspection was performed, and no abnormalities were found.The reported issue could not be reproduced during the device evaluation.The pump was tested with at 40ml/hr and 125ml/hr and found to deliver within specification.The device was determined to meet all product specifications related to the reported event.The reported device failed to infuse was not verified.Evaluation determined no action required at this time.Should additional relevant information become available, a supplemental report will be submitted.
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It was reported that a spectrum iq pump failed to infuse dexmedetomidine during therapy.The drug solution was indicated for sedation and programmed at the rate of 4 ug/ml at the prescribed dose of 1 ug/kg/hr and was set up to be infused for greater than two hours.The pump displayed messages such as 'infusing' and 'infusion complete' but no medication was infused.Further details from the report indicate that the patient was being infused with the medication and the pump alerted that the volume of medication being infused was complete.The nurse added 20 more cc of medication to be infused over 2 hours.The sedated patient began to display restlessness and the nurse proceeded to increase the rate of infusion.The nurse then noted that the volume of medication had not changed.No drip was noted in the tubing and the pump was replaced.Follow-up with the customer reported the patient was described to experience "no patient injury, [no] medical intervention, [and no] symptom or adverse event.No additional information is available.
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