Model Number 8100 |
Device Problem
No Fail-Safe Mechanism (2990)
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Patient Problem
Infiltration into Tissue (1931)
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Event Type
malfunction
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Manufacturer Narrative
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Concomitant medical products: 24 gauge bd insyte autoguard or 22 gauge bd nexia diffusics.No device will be returned per customer.The customer declined to return the device for failure investigation.The root cause of this failure was not identified.The customer stated that the patient ages ranged from 5 weeks of age to 16 years of age.Males and females with varying diagnosis and medical histories.Date of event was requested but not provided.
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Event Description
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It was reported infiltrations occurred in the pediatric population, five of which did not require surgical intervention out of seven infiltrates.The patients ranged from 5 weeks of age to 16 years of age.Males and females were affected, and the patients had different admission diagnoses and medical history.There was no long term permanent injury that is known.The five infiltrate events captured in this file resulted in requiring an iv change.The events occurred while primary fluids were infusing and ranged from d51/2 ns with 20k, d5ns, and d5 ns and 20k.Alarms were not a factor in these events.The patient's either had a 24 or 22 gauge iv.
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Event Description
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It was reported infiltrations occurred in the pediatric population, five of which did not require surgical intervention out of seven infiltrates.The patients ranged from 5 weeks of age to 16 years of age.Males and females were affected, and the patients had different admission diagnoses and medical history.There was no long term permanent injury that is known.The five resulted in requiring an iv change.The events occurred while primary fluids were infusing and ranged from d51/2 ns with 20k, d5ns, and d5 ns and 20k.Alarms were not a factor in these events.The patient's either had a 24 or 22 gauge iv.
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Search Alerts/Recalls
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