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Catalog Number CX-XRX35920 |
Device Problem
Infusion or Flow Problem (2964)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/04/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Udi - not required for product code.Implanted date: device was not implanted.Explanted date: device was not explanted.Occupation-clinical engineer.Pma/510(k)- k130520.The actual device was not returned; therefore, an evaluation of the actual device was unable to be conducted.A review of the device history record and product-release judgement record of the involved product code/lot# combination was conducted with no findings.Ifu states: do not reduce heparin during circulation.Otherwise, blood clotting might occur.Adequate heparinization of the blood is required to prevent it from clotting in the system.It is likely that blood clots were formed and clogged the cr filter due to blood with activated coagulation factors flowed into the reservoir; blood clots and tissue fragment sucked from the surgical field flowed into the reservoir, resulting in the clogging.However, with no device return the exact cause of the reported event cannot be definitively determined based on the available information.(b)(4).
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Event Description
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The user facility reported the capiox device was used during the procedure.It was a thoracic aorta case.In less than 30 minutes from the start of circulation, the cr filter of the reservoir rr40v clogged, the pressure at the cr part increased, and suction became impossible.Another rr40v was added and used as cr.It was connected to the 3/8 port next to the inlet port.The procedure outcome was not reported.The patient was not harmed.
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Search Alerts/Recalls
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