Model Number 400CE |
Device Problem
Output Problem (3005)
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Patient Problem
Alteration in Body Temperature (4568)
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Event Type
malfunction
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Manufacturer Narrative
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Complaint #(b)(4) received.The customer concluded the heating element was not functioning.There were no allegations of patient harm.To date, the device has not returned for evaluation.
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Event Description
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The perfusionist had the patient on bypass and noticed temperature of the patient was low, the device set point was at 37 but the actual temperature was 32.The customer checked the flow indicator and it was showing forward flow.The device was changed out with blanketrol devices without incident.The hemotherm 400ce device was sent to biomed to help diagnose issue.Biomed determined the heating element was not functioning.
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Manufacturer Narrative
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The device was returned for evaluation on august 4, 2021.The customer issue was confirmed; the heater was defective.The heater was replaced to correct.
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Search Alerts/Recalls
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