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Catalog Number 3570009 |
Device Problem
Failure to Sense (1559)
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Patient Problem
Increased Respiratory Rate (2486)
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Event Date 01/20/2021 |
Event Type
Injury
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Event Description
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It was reported that during patient infusion of fentanyl with a spectrum iq pump, the patient experienced tachypnea, reported as" breathing rapidly" despite having increased sedatives and a fentanyl bolus.It was further reported the fentanyl wasn't flowing, even though the pump was on and had been running for 16 hours with no occlusion alarms generated.According to the reporter, the pump ¿read the fentanyl was flowing normally¿.A kink was found in the tubing above the pump that was obstructing flow.Treatment for the event was not reported.At the time of this report, the patient outcome was not reported.No additional information is available.
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Manufacturer Narrative
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The device was not returned, and the serial number is unknown; therefore, a device analysis could not be completed.The likely cause of the reported event was associated with use error, related to the kinked tubing.The spectrum pump operating manual for the user to ensure that iv sets or container vents are properly functioning, that tubing clamps are in the proper positions and that tubing is free from kinks or signs of collapse outside the pump to prevent undetected upstream occlusions.Should additional relevant information become available, a supplemental report will be submitted.
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Search Alerts/Recalls
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