Catalog Number 50000000 |
Device Problem
Insufficient Cooling (1130)
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Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 04/08/2024 |
Event Type
malfunction
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Event Description
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It was reported that the biomed requesting assistance with the arctic sun device that was not cooling in manual control below 73.9f.
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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.H3 other text : the device was not returned.
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Manufacturer Narrative
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The reported issue was confirmed.The root cause was isolated to a faulty mixing pump.It was noted that the biomed requesting assistance with the arctic sun device that was not cooling in manual control below 73.9f.It was stated the mixer was not working, it has been replaced.There were no issues.Dhr is not required as the reported event is not an out of box failure and therefore the reported event is not manufacturing related.The labelling review is not required as the complaint or reported issue was confirmed through other elements of the investigation to not be labeling or packaging 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 the biomed requesting assistance with the arctic sun device that was not cooling in manual control below 73.9f.Per follow up information received via phone on 01may2024, it was reported that customer stated the mixer was not working, it has been replaced.There were no issues.
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Search Alerts/Recalls
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