Catalog Number 5000-01-01 |
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 04/15/2024 |
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.
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Event Description
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It was reported that the water of the arctic sun device did not get cold.Per review of wo on 16apr2024, there was no patient involvement.Per follow up information received via mail on 25apr2024, it was reported that they repaired the device on the customer site.The problem was cooling malfunction, and the defective part was chiller pump.They replaced the chiller pump.The issue was resolved.
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Manufacturer Narrative
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The reported issue was confirmed.The root cause identified is a failed chiller pump.Checked chiller pump: it was defective.Pipes of chiller assy was frozen.Replaced chiller 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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Event Description
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It was reported that the water of the arctic sun device did not get cold.Per review of wo on 16apr2024, there was no patient involvement.Per follow up information received via mail on 25apr2024, it was reported that they repaired the device on the customer site.The problem was cooling malfunction, and the defective part was chiller pump.They replaced the chiller pump.The issue was resolved.
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Search Alerts/Recalls
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