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Model Number 50000000E |
Device Problem
Insufficient Heating (1287)
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Patient Problems
Death (1802); Respiratory Distress (2045)
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Event Type
malfunction
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Manufacturer Narrative
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The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.
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Event Description
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It was reported that a patient was insufficiently heating while receiving therapy on an arctic sun device.The patient¿s temperature was 33.8c and the target was 37c.The water temperature was 39.8c and the flow rate was 2.1l/min.The rewarm tab read from 34.8c, at a rate of 0.50c/hour to 37c.Per troubleshooting with ms&s, the nurse added a universal pad and warm blankets.The nurse also turned on the vent warmer and increased the room temperature.A few hours passed and the patient still did not meet the rewarm target.The patient¿s temperature was then 34.4c and the water temperature was 42c.During a follow up call on (b)(6) 2019, the assistant nurse manager, (b)(6), stated the patient was admitted to the icu for respiratory distress and was also receiving continuous renal replacement therapy (crrt).The patient completed therapy on (b)(6) 2019 and was later placed on comfort care measures.Nurse (b)(6) stated the patient expire on (b)(6) 2019 and the cause of death was due to anoxic brain injury related to respiratory distress and was not device related.
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Manufacturer Narrative
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Per medical affairs review bard/bd has determined that this mdr was initially reported in error as this event is not reportable.
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Event Description
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It was reported that a patient was insufficiently heating while receiving therapy on an arctic sun device.The patient¿s temperature was 33.8c and the target was 37c.The water temperature was 39.8c and the flow rate was 2.1l/min.The rewarm tab read from 34.8c, at a rate of 0.50c/hour to 37c.Per troubleshooting with ms&s, the nurse added a universal pad and warm blankets.The nurse also turned on the vent warmer and increased the room temperature.A few hours passed and the patient still did not meet the rewarm target.The patient¿s temperature was then 34.4c and the water temperature was 42c.During a follow up call on 04-nov-2019, the assistant nurse manager, (b)(4), stated the patient was admitted to the icu for respiratory distress and was also receiving continuous renal replacement therapy (crrt).The patient completed therapy on (b)(4) 2019 and was later placed on comfort care measures.Nurse (b)(4) stated the patient expire on (b)(4) 2019 and the cause of death was due to anoxic brain injury related to respiratory distress and was not device related.
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Search Alerts/Recalls
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