Catalog Number 5000-01-02 |
Device Problems
Failure to Pump (1502); Pumping Problem (3016)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/27/2024 |
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 they might be chiller pump oder chiller could be defective in an arctic sun device.During visual inspection there was no damage and quick test was performed.Device could only be filled with 3 liters.Due to the defective mixing pump, no water could get into the cooling tank, which could then be cooled.Circulation pump was at the wear limit.
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Manufacturer Narrative
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The reported issue was confirmed.The root cause identified as a mixing pump failure.The dhr is not required as this is not an out-of-box failure.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 actual/suspected device was inspected.
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Event Description
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It was reported that they might be chiller pump older chiller could be defective in an arctic sun device.During visual inspection there was no damage and quick test was performed.Device could only be filled with 3 liters.Due to the defective mixing pump, no water could get into the cooling tank, which could then be cooled.Circulation pump was at the wear limit.
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Search Alerts/Recalls
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