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Catalog Number 50000000E |
Device Problems
Defective Component (2292); Material Split, Cut or Torn (4008)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/14/2024 |
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 found that the tank seal for the outlet of the circulation pump and inlet of the mixing pump was torn in an arctic sun device.Per sample evaluation results on 14mar2024, it was reported that during replacement of the coin cell, it was found that the nut plate securing the control panel bracket to the outer shell was stripped and spinning in the outer shell, preventing proper attachment of the bolt.The circulation pump motor was found to have a worn bearing.
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Event Description
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It was found that the tank seal for the outlet of the circulation pump and inlet of the mixing pump was torn in an arctic sun device.Per sample evaluation results on 14mar2024, it was reported that during replacement of the coin cell, it was found that the nut plate securing the control panel bracket to the outer shell was stripped and spinning in the outer shell, preventing proper attachment of the bolt.The circulation pump motor was found to have a worn bearing.
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Manufacturer Narrative
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The reported issue was confirmed.The root cause of the reported issue is a failed circulation pump.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 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 actual/suspected device was inspected.
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Search Alerts/Recalls
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