MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA CAPIOX HOLLOW FIBER OXYGENATOR/ARTERIAL FILTER; OXYGENATOR, CARDIOPULMONARY BYPASS

Catalog Number CX*FX05RW

Device Problem Air/Gas in Device (4062)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/19/2021

Event Type  malfunction  

Manufacturer Narrative

Implanted date: device was not implanted.Explanted date: device was not explanted.Occupation- ccp.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 the involved product code/lot# combination was conducted with no findings.(b)(4).

Event Description

The user facility reported an air bubble on the capiox device oxygenator during cardiopulmonary bypass.There was no delay with beginning or continuing the procedure; the product was changed out.The procedure was completed successfully without harm to the patient.There was no blood loss.

Manufacturer Narrative

This report is being submitted as follow up no.2 to provide the device return date in section d9, update section h3, and to provide the completed investigation results.The actual sample was received for evaluation.Visual inspection revealed no anomaly including a breakage that could lead to air on oxygenator.After rinsing and drying the actual sample, it was installed into a circuit consisting of tubes, and the saline solution was circulated by a roller pump.No leakage was found that could lead to residual air or mixed air.Bovine blood (37°c, hb12g/dl) was circulated in the actual sample under the conditions of back pressure 200mmhg, blood flow rate 0.5l/min, 1.0l/min, 1.5l/min, and in order to confirm the air bubble removal performance, 10 ml of air was flowed from the oxygenator inlet port side over 30 seconds.No air outflow was observed from the oxygenator through the filter (after connecting the arterial filter to the blood outlet port side and letting air flow in from the blood inlet port side, the presence or absence of air outflow to the oxygenator and the arterial filter is confirmed).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 5l/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 0.5l/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 results verified the returned sample was of normal product.It was likely that air flowed into the oxygenator for some reason, or air remained during priming.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.1 to provide a correction to section d4.The expiration date and unique identifier (udi)# was inadvertently initially submitted incorrectly.Therefore, the correct information has been provided.

• Brand Name: CAPIOX HOLLOW FIBER OXYGENATOR/ARTERIAL FILTER
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• MDR Report Key: 12299779
• MDR Text Key: 265806135
• Report Number: 9681834-2021-00141
• Device Sequence Number: 1
• Product Code: DTZ
• UDI-Device Identifier: 04987350781758
• UDI-Public: 04987350781758
• 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,health
• Type of Report: Initial,Followup,Followup
• Report Date: 08/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2023
• Device Catalogue Number: CX*FX05RW
• Device Lot Number: 200821
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2021
• Initial Date Manufacturer Received: 07/20/2021
• Initial Date FDA Received: 08/10/2021
• Supplement Dates Manufacturer Received: 08/15/2021; 08/17/2021
• Supplement Dates FDA Received: 08/16/2021; 09/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1