Catalog Number 50000000E |
Device Problem
Insufficient Information (3190)
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Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 12/07/2023 |
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.H3 other text : the device was not returned.
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Event Description
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It was reported that the customer had replaced the circulation pump but it was failed for pressure.A check of the arctic sun device in bypass showed it was only able to generate -2 psi.This was indicative of a leak somewhere and checked the fluid delivery line, manifold, and connections to the inlet of the circulation pump.
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Manufacturer Narrative
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Upon further review of investigation, bd has determined that this mdr is not reportable as investigation confirmed it is a use 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 customer had replaced the circulation pump but it was failed for pressure.A check of the arctic sun device in bypass showed it was only able to generate -2 psi.This was indicative of a leak somewhere and checked the fluid delivery line, manifold, and connections to the inlet of the circulation pump.
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Search Alerts/Recalls
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