TERUMO CORPORATION, ASHITAKA CAPIOX RX25 OXYGENATOR/RESERVOIR (LF PORT); OXYGENATOR, CARDIOPULMONARY BYPASS
|
Back to Search Results |
|
Catalog Number 1CX*RX25RW |
Device Problem
Infusion or Flow Problem (2964)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 12/03/2021 |
Event Type
malfunction
|
Event Description
|
The user facility reported that during priming of the capiox device, there was air coming from arterial outlet.There was no delay in the procedure, the product was changed out and the surgery was completed successfully with no patient effect, there was no blood loss.
|
|
Manufacturer Narrative
|
Implanted date: device was not implanted.Explanted date: device was not explanted.Occupation- technologist.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 decision control sheet of the involved product code/lot# combination was conducted with no findings.Ifu states: do not obstruct gas outlet port.Avoid build up of excess pressure in the gas phase to prevent gaseous emboli entering the blood phase.Pressure in the blood phase should always be higher than that in the gas phase to prevent gaseous emboli entering the blood phase.The gas flow rate should not exceed 20l/min.Excessive gas flow rate will bring about pressure increase in the gas phase, allowing gaseous emboli to enter the blood phase.During recirculation, do not use pulsatile flow and do not stop the blood pump suddenly as these actions may cause gaseous emboli to enter the blood phase from the gas phase due to inertia force.To prevent gaseous emboli from entering the blood phase, make sure that the arterial pump flow rate always exceeds the flow rate of the cardioplegia line.The blood flow rate of the cardioplegia line should not exceed 1l/min.Minimum operating volume in the reservoir is 200ml.Set appropriate blood storage level, relative to venous flow rate, to prevent gaseous emboli passing to patient.Recirculate the priming solution at a rate of 4l/min or higher to facilitate air removal.Failure to remove air from the oxygenator may result in serious injury to the patient.Ensure that the de-airing process is complete prior to initiating bypass.With no device return the exact cause of the reported event cannot be definitively determined based on the available information.(b)(4).
|
|
Search Alerts/Recalls
|
|
|