Model Number 50000000E |
Device Problem
Nonstandard Device (1420)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/05/2022 |
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.
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Event Description
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It was reported that the biomed had an arctic sun device that would not cool, mixing pump appeared to have failed.The device was giving 2000-hour preventive maintenance information.Per sample evaluation, it was reported that tank tubing found expanded.
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Event Description
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It was reported that the biomed had an arctic sun device that would not cool, mixing pump appeared to have failed.The device was giving 2000-hour preventive maintenance information.As per sample evaluation, it was reported that tank tubing found expanded.As per sample evaluation results received on 24mar2023, it was reported that the tank tubing such as l shape formed tube and double bend tube were expanded.The l shape formed tube and double bend tube were replaced.
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Manufacturer Narrative
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Upon further review, bd has determined that this mdr event is not reportable. 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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