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Catalog Number 50000000 |
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 12/09/2023 |
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 the patient was rewarming to a target of 37c.They were getting alert 113 (reduced water temperature control) in an arctic sun device.Patient temperature (pt) was 35.2c, water temperature (wt) was 29.8c.Flow rate (fr) was 2.0lpm.Rewarm from 35.8c at a rate of 0.25c/hr.Heater command was 100 percentage, water reservoir level (wrl) was 5, pump hours were 4962.2.System hours were 5509.1.Walked nurse through draining water from circulation tank.Water temperature increased to 35c by the end of the call.Discussed how overfill could occur.
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Manufacturer Narrative
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Per investigator evaluation, bd has determined that this mdr event is not reportable.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.H3 other text : the device was not returned.
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Event Description
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It was reported that the patient was rewarming to a target of 37c.They were getting alert 113 (reduced water temperature control) in an arctic sun device.Patient temperature (pt) was 35.2c, water temperature (wt) was 29.8c.Flow rate (fr) was 2.0lpm.Rewarm from 35.8c at a rate of 0.25c/hr.Heater command was 100 percentage, water reservoir level (wrl) was 5, pump hours were 4962.2.System hours were 5509.1.Walked nurse through draining water from circulation tank.Water temperature increased to 35c by the end of the call.Discussed how overfill could occur.
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Search Alerts/Recalls
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