MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA CAPIOX FX OXYGENATOR; OXYGENATOR, CARDIOPULMONARY BYPASS

Catalog Number ZZ*FX05RE

Device Problem Device Difficult to Setup or Prepare (1487)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/01/2019

Event Type  malfunction  

Manufacturer Narrative

Implanted date: device was not implanted.Explanted date: device was not explanted.The 510(k) no: k130280.Potential lot number: 180705, expiration date: 30jun2021, manufacture date: 05july2018.The actual device has not been returned for evaluation.The investigation is currently ongoing.A follow up report will be submitted once the investigation is complete.A review of the device history record and product release decision control sheet of both said reported product code/lot number combinations revealed no findings.(b)(4).

Event Description

The user facility reported that the capiox device was used during the procedure.There was an unexpected aeration of oxygenator during cpb.There was no harm to the patient.The procedure outcome was not reported.

Manufacturer Narrative

This report is being submitted as follow up no.1 to provide additional information in event.The type of event has been deemed a malfunction based off the additional information provided; therefore, adverse event or product problem and type of reportable event have been updated to reflect malfunction.

Event Description

Additional information was received on 27nov2019.The actual device was changed out prior to use on the patient.

Event Description

Additional information was received on 27nov2019.The pump was stopped and clip clamped the main tube.Massive aeration of blood side of the oxygenator occurred immediately.

Manufacturer Narrative

This report is being submitted as follow up no.3 to provide the device return date in section d10, update section h3, and to provide the completed investigation results.Two potential lot numbers were initially provided.The actual lot number was confirmed; therefore, sections d4 and h4 have been updated.The actual sample was received for evaluation.Visual inspection revealed no obvious anomaly, such as a break, in the appearance.The actual sample was rinsed, subjected to another closer visual inspection, and then confirmed not to have any anomaly, such as a break, which could have caused air to enter the oxygenator.The tube connected to the blood outlet port of the oxygenator and the purge line were confirmed have no break or no other anomaly.The actual sample was built into a circuit with tubes and primed with saline solution in accordance with the ifu for this product.Any leak that could have caused air to remain in or to enter the actual sample was not observed.The actual sample was tested its air bubble removal performance in accordance with the product inspection protocol; it was built into a circuit with tubes and circulated with bovine blood (37°c and hb12g/dl) at the back pressure of 200mmhg and at each blood flow rate of 0.5l/min., 1.0l/min., and 1.5l/min.During circulation at each flow rate, an air of 10ml was sent into the circulation over 30 seconds.No air came out of the oxygenator through the filter.Ifu states: minimum operating volume in the reservoir is 15ml volume below 15ml will pull air from the reservoir.Set appropriate blood storage level, relative to venous flow rate, to prevent gaseous emboli passing to patient.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 0.5 l/min.The gas flow rate should not exceed 5 l/min.Excessive gas flow rate will bring about pressure increase in the gas phase, allowing gaseous emboli to enter the blood phase.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.Based on the provided information and investigation results, there is no definitive evidence that this event was related to a device defect or malfunction.The investigation results verified the returned sample was of the normal product.It is likely that when the flow of the priming solution going into the oxygenator module was cut off by a sudden stop of the pump or by the clamping, the priming solution inside the oxygenator module was still flowing out of the oxygenator module by inertial force.As a result, the pressure inside the oxygenator became negative causing air to enter inside it through the fiber.The liquid level inside the reservoir or the point of monitoring the air during the event were unknown.However, the exact cause of the reported event cannot be definitively determined based on the available information.

Manufacturer Narrative

This report is being submitted as follow up no.2 to update sections d10 and h3, and to provide the completed investigation results.It was initially reported that the actual device was available for investigation; however, it was confirmed that the device was no longer available.The actual device was not received for evaluation.Therefore, the investigation was based on user facility information and evaluation of the factory-retained samples from the two possibly involved lot numbers.Visual inspection revealed no obvious anomaly, such as a break, in the appearance.Each sample was built into a circuit with tubes and primed with saline solution in accordance with the ifu for this product.Any leak that could cause air to remain or enter in the blood channel was not observed.Each sample was built into a circuit with tubes and circulated with bovine blood (@37°c and hb12g/dl) at the backpressure of 200mmhg and at each blood flow rate of 0.5l/min., 1.0l/min., and 1.5l/min.During circulation at each flow rate, an air of 10ml was sent into the circulation over 30 seconds.No air came out through the filter.An arterial filter was connected into the blood outlet port line and air was sent into the oxygenator module from the blood inlet port, while the circuit was closely observed for any air bubbles going out of the oxygenator module toward the arterial filter.Ifu states: ensure that the de-airing process is complete prior to initiating bypass.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.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 5 l/min.Excessive gas flow rate will bring about pressure increase in the gas phase, allowing gaseous emboli to enter the blood phase.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 0.5 l/min.Based on the provided information and investigation results, there is no definitive evidence that this event was related to a device defect or malfunction.The investigation result verified that the retention samples were the normal products without any leak that could cause air to enter the oxygenator module, having the normal air removal performance.It is likely that air entered the oxygenator module due to some factor(s) or that air was not completely removed from the device during the priming.However, with no return of the actual device, the exact cause of the reported event cannot be definitively determined based on the available information.

• Brand Name: CAPIOX FX OXYGENATOR
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• MDR Report Key: 9376070
• MDR Text Key: 168041068
• Report Number: 9681834-2019-00202
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• PMA/PMN Number: K071572
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2021
• Device Catalogue Number: ZZ*FX05RE
• Device Lot Number: 180705
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2020
• Date Manufacturer Received: 01/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 7 MO
• Patient Weight: 7