Catalog Number 50000000E |
Device Problems
Insufficient Cooling (1130); Failure to Pump (1502)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/09/2024 |
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.The device was not returned.
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Event Description
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It was reported that they stated that the arctic sun device would not cool.During functional check it was determined that there was a failed mixing pump.Empty chiller tank.They requested parts and pricing and would make the repair onsite.
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Event Description
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It was reported that they stated that the arctic sun device would not cool.During functional check it was determined that there was a failed mixing pump.Empty chiller tank.They requested parts and pricing and would make the repair onsite.
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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 arctic sun device would not cool.During functional check it was determined that there was a failed mixing 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 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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Search Alerts/Recalls
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