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Catalog Number 2H8603 |
Device Problem
Device Operates Differently Than Expected (2913)
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Patient Problem
Hypoglycemia (1912)
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Event Date 10/04/2016 |
Event Type
Injury
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Manufacturer Narrative
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(b)(6).Should additional relevant information become available, a supplemental report will be submitted.
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Event Description
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A hypoglycemic pediatric patient experienced a drop in glucose level while using a clearlink solution set with filter.It was reported that the nurse "thought they had the baby's glucose level managed after a few boluses of 10% dextrose (no further detail was provided) and then changing the baby to d15w (not further specified), however, the baby experienced another dramatic drop in glucose level further described as "back down into the 20's around 0230 hours." the filter was removed and after 30 minutes, the infant's glucose level went from 29 to 75 (units not reported) and eventually 100 (units not reported) and the infant was being weaned from the d15w.No further information was provided regarding the patient's outcome from the event.No additional information is available.
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Manufacturer Narrative
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The device was not returned and the lot number is unknown; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.
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Search Alerts/Recalls
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