Catalog Number 12220 |
Device Problems
Fluid/Blood Leak (1250); Leak/Splash (1354)
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Patient Problems
Blood Loss (2597); No Known Impact Or Consequence To Patient (2692)
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Event Date 11/13/2019 |
Event Type
malfunction
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Manufacturer Narrative
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Investigation: per the customer, the reported event occurred to the different nurses on different machines 5 times for the same reported disposable lot number.Investigation is in-process.A follow-up report will be provided.
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Event Description
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The customer reported a leak occurred on the disposable set during a procedure on spectra optia.Per the customer, an unknown amount of blood loss occured.It is unknown at this time if medical intervention was required for this event.The patient information and outcome is not available at this time.The optia exchange set is not available for evaluation as it was discarded by the customer.
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Manufacturer Narrative
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This report is being filed to provide additional information in description of event or problem and adverse event problem.Investigation is in process.A follow-up report will be provided.
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Event Description
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After multiple follow-up attempts, the customer did not provide patient info, outcome or additional procedural details for this event.
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Manufacturer Narrative
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This report is being filed to provide additional information in e.3, h.6, and h10.Investigation: a disposable history search was performed for lot 1910163230 and no similar reported occurrences have been received.Root cause:the root cause for the reported tubing set leak could not be determined.The cause of a leak at a component or assembly may be due to a hole in the component or assembly, an incomplete bond at the assembly, a welding issue, or a breakage at the tubing bond.
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Manufacturer Narrative
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This report is being filed to provide additional information in h.6 and h.10.Investigation: the device history record was reviewed for this lot.There were no issues noted that would have contrbuted to set leak experienced by the customer.Investigation is in process.A follow up report will be provided.
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Search Alerts/Recalls
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