Lot numbers: 190705, 190729, or 191023.Expiration date - lot.:190705 june 30, 2022; lot.:190729 june 30, 2022; lot.:191023; september 30, 2022.Udi: not required for product code.Implanted date: device was not implanted; explanted date: device was not explanted; occupation-ccp.Device manufacturer date - lot.: 190705 july 5, 2019; lot.:190729 july 29, 2019; lot.:191023 october 23, 2019.The actual device was not returned, therefore, an evaluation of the actual device was unable to be conducted.A picture was provided by the user facility, and revealed a formation of substance that seemed to be white clots on the oxygenator filter surface.The result of the performance test (the pressure drop measured during the circulation of bovine blood at hct 35% and temp.37° c) conducted before the shipment from the factory for the same fiber lot product as the actual product was reviewed, and it was confirmed that the performance value was confirmed to be within the control criteria.A review of the device history record and product-release judgement record of the involved product code/lot# 190705 or 190729 or 191023 combinations 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.With no return of the actual device, the exact cause of the reported event cannot be definitively determined based on the available information.(b)(4).
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The user facility reported that the involved capiox device was used during cardiopulmonary bypass.Fibrin was pulsating on the fiber bundle.During cpb, ccp noticed what looked like to be fibrin pulsating on the fiber bundle.The device was not changed out, the surgery was completed successfully.There was no patient injury, and there was no blood loss.The approximate time of occurrence was 9:01am.The event did not delay the procedure.
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