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Catalog Number 60000000 |
Device Problems
Insufficient Heating (1287); Overfill (2404)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/01/2024 |
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.H11: section a through f - the information provided by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
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Event Description
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It was reported that they had a patient being treated on arctic sun device.The target temperature was set to 36c, but the patient temperature was 34.7c.They have restarted and reprogrammed the device, but the patient temperature was still at 34.7c.Target temperature was 36c, in hypothermia.Patient temperature was 34.7c.Flow rate was 3.4lpm.Water temperature was 27.8c.Event log shows alarms 50 (patient temperature 1 erratic), 45 (ac power lost), 5 (water reservoir empty), and 116 (patient temperature not changed).Water level 5.Heater command 100 percentage.Nurse confirms filling reservoir when they got alarm 5.Walked nurse through draining excess water from circulation tank.Water up to 30.6c and increasing.
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Manufacturer Narrative
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Per investigational findings, bd has determined that this mdr as not reportable as the reported event was confirmed as user related.H11: section a through f - the information provided by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
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Event Description
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It was reported that they had a patient being treated on arctic sun device.The target temperature was set to 36c, but the patient temperature was 34.7c.They have restarted and reprogrammed the device, but the patient temperature was still at 34.7c.Target temperature was 36c, in hypothermia.Patient temperature was 34.7c.Flow rate was 3.4lpm.Water temperature was 27.8c.Event log shows alarms 50 (patient temperature 1 erratic), 45 (ac power lost), 5 (water reservoir empty), and 116 (patient temperature not changed).Water level 5.Heater command 100 percentage.Nurse confirms filling reservoir when they got alarm 5.Walked nurse through draining excess water from circulation tank.Water up to 30.6c and increasing.
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Search Alerts/Recalls
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