Model Number 8110 |
Device Problems
Device Alarm System (1012); Insufficient Information (3190)
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Patient Problem
Extravasation (1842)
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Event Date 10/27/2021 |
Event Type
Injury
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Manufacturer Narrative
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A follow up report will be submitted with investigation results should the device be repaired or the device/logs be received for evaluation.Per 803.52(f)(11)(iii) the information provided represents all of the known information at this time.The complainant or reporter was unable or unwilling to provide any further patient, product, or procedural details to the manufacturer.Device was not returned to manufacturing facility.
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Event Description
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It was reported that a term infant receiving a hypertonic dextrose infusion for the management of hypoglycemia developed a fulminating extravasation shortly after commencement of the infusion.This complication developed without notification of syringe pump pressure changes pertaining to a change in blood vessel compliance or early warning of infiltration by the optical sensor site monitoring technology (non-bd device) in use.The injury was extensive and treated with a hyaluronidase/saline mix subcutaneously injected into the extravasation site using established techniques.Over a period of 2 weeks, the initially deep wound healed successfully without further incident, and the infant was discharged home without evident cosmetic scarring or functional effects.
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Event Description
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It was reported that a term infant receiving a hypertonic dextrose infusion for the management of hypoglycemia developed a fulminating extravasation shortly after commencement of the infusion.This complication developed without notification of syringe pump pressure changes pertaining to a change in blood vessel compliance or early warning of infiltration by the optical sensor site monitoring technology (non-bd device) in use.The injury was extensive and treated with a hyaluronidase/saline mix subcutaneously injected into the extravasation site using established techniques.Over a period of 2 weeks, the initially deep wound healed successfully without further incident, and the infant was discharged home without evident cosmetic scarring or functional effects.
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Search Alerts/Recalls
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