Catalog Number 50000000E |
Device Problems
Inaccurate Flow Rate (1249); Failure to Pump (1502)
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Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 02/20/2024 |
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.H3 other text : the device was not returned.
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Event Description
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It was reported that the arctic sun device was having low flow alarms.A check of the diagnostics showed that the circulation pump would not generate any pressure.They requested a quote for the 2000 hour service.No loaner needed.
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Manufacturer Narrative
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The reported issue was confirmed.The root cause of the reported issue is a circulation pump component failure.A check of the diagnostics showed that the circulation pump would not generate any pressure.They requested a quote for the 2000 hour service.No loaner needed.A dhr review 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.Correction: f,h.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 arctic sun device was having low flow alarms.A check of the diagnostics showed that the circulation pump would not generate any pressure.They requested a quote for the 2000 hour service.No loaner needed.
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Search Alerts/Recalls
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