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Model Number 8100 |
Device Problems
Break (1069); Crack (1135)
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Patient Problem
Hypoglycemia (1912)
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Event Date 03/13/2023 |
Event Type
Injury
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Manufacturer Narrative
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A device history record review is performed on each device reported in a mdr reportable event along with other methods of investigation as coded in this mdr report.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.No devices received, log review only.
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Event Description
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It was reported a clinician hung an infusion of insulin (100units/100ml) and programmed infusion to run at 5mls/hr.When clinician entered the room one our later to check the patient blood sugar it was noticed the bag was empty.The pump still showed there was 78.9 mls left to be infused.The patient had a drop in blood sugar and potassium levels.The infusion was stopped, iv fluid boluses were given.Patient required frequent blood glucose checks and well as repeat lab work.The pump was removed from service.Upon customer's biomed inspection of the device following the event, it was noted there was broken upper platen hinge.
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Event Description
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It was reported a clinician hung an infusion of insulin (100units/100ml) and programmed infusion to run at 5mls/hr.When clinician entered the room one our later to check the patient blood sugar it was noticed the bag was empty.The pump still showed there was 78.9 mls left to be infused.The patient had a drop in blood sugar and potassium levels.The infusion was stopped, iv fluid boluses were given.Patient required frequent blood glucose checks and well as repeat lab work.The pump was removed from service.Upon customer's biomed inspection of the device following the event, it was noted there was broken upper platen hinge.A report was received from health canada's canada vigilance program which states, "patient arrived with ems, venous glucose was 41 and k+ was 6.7.Insulin infusion initiated at 5 units per hour per order.Pump set and double checked by 3 individuals.100 units of toronto insulin in 100 mls of ns hung at 1300 hrs and writer went in to do poc glucose at 1400 and sugar was 24.9.Writer assessed pump, found mini bag of insulin empty.Channel display shows that 78.9 mls to be infused and writer had programmed it at 85 mls (including primed line).Writer called another rn and unit manager to witness error in pump.Ed physician aware, photos taken and attached.Pump tagged and removed from unit.".
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Search Alerts/Recalls
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