Catalog Number 50000000 |
Device Problems
Restricted Flow rate (1248); Decreased Pump Speed (1500)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/03/2024 |
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.The device was not returned.
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Event Description
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It was reported that the arctic sun device would not take up any water during the filling process.There was no suction from left port of manifold and failed circulation pump.Requested a quote for 2000-hour service so that they might order a circulation pump and replace in house.Per additional information received via phone on 22apr2024, it was reported that they discovered the device needs a mixing pump and a circulation pump.They will replace them.The device will not come in for evaluation.
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Manufacturer Narrative
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The reported issue was confirmed.The root cause identified as a circulation pump failure.There was no suction from left port of manifold and failed circulation pump.A 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 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.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 would not take up any water during the filling process.There was no suction from left port of manifold and failed circulation pump.Requested a quote for 2000-hour service so that they might order a circulation pump and replace in house.Per additional information received via phone on 22apr2024, it was reported that they discovered the device needs a mixing pump and a circulation pump.They will replace them.The device will not come in for evaluation.
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Search Alerts/Recalls
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