MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA CAPIOX RX25 OXYGENATOR; OXYGENATOR, CARDIOPULMONARY BYPASS

Catalog Number CX*RX25RW

Device Problem Infusion or Flow Problem (2964)

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

Event Date 07/19/2022

Event Type  malfunction  

Event Description

The user facility reported that while priming the capiox device cpb circuit, the perfusionist observed that there was air bubble formation inside the oxygenator chamber which was quite significant and forced him to replace the oxygenator with new one.This was observed when he was trying to stop the pump and the air could be seen going into the arterial line.Replacement of the oxygenator with new one.The event occurred pre-treatment.The patient was not harmed.

Manufacturer Narrative

Implanted date: device was not implanted.Explanted date: device was not explanted.Health professional: unknown.Occupation: unknown.The actual device was not returned; therefore, an evaluation of the actual device was unable to be conducted.From our experience, it was inferred that the following factors may have caused air entering the oxygenator, which resulted in the air bubbles flowing out of the oxygenator during priming.When the roller pump was suddenly stopped during priming, the pressure inside the oxygenator became negative and air was drawn through the fiber.When the flow rate of the cardioplegia side was higher than the main side, the pressure inside the oxygenator became negative and air was drawn through the fiber.Review of the manufacturing record and product-release judgement record confirmed there was no indication of anomaly in them.A search of the complaint file found no other similar reports with the above-mentioned product code/lot number combination.No anomaly was confirmed in the manufacturing record or the product-release judgement record of the actual sample.As a possible cause in this case, from our experience, it was inferred that the pressure inside the oxygenator might have become negative causing air to be drawn through the fiber.However, since the actual sample was not returned and inspection could not be performed, the cause of occurrence could not be clarified.Relevant ifu (instructions for use) reference: (i) do not obstruct gas outlet port.Avoid build up of excess pressure in the gas phase to prevent gaseous emboli entering the blood phase.(warnings).(ii) pressure in the blood phase should always be higher than that in the gas phase to prevent gaseous emboli entering the blood phase.(warnings).(iii) 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.(warnings).(iv) 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.(warnings).(v) 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.(warnings).(vi) 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.(warnings).(vii) 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.(b.Priming procedure caution).(viii) ensure that the de-airing process is complete prior to initiating bypass.(c.Initiation of bypass caution).(b)(4).

• Brand Name: CAPIOX RX25 OXYGENATOR
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• Manufacturer (Section G): TERUMO CORPORATION, ASHITAKA; reg. no. 9681834; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• Manufacturer Contact: stephanie handy ; reg. no. 2243441; 950 elkton blvd.; elkton, MD 21921 ; 9499890491
• MDR Report Key: 15188174
• MDR Text Key: 304893074
• Report Number: 9681834-2022-00164
• Device Sequence Number: 1
• Product Code: DTZ
• UDI-Device Identifier: 04987350769572
• UDI-Public: 04987350769572
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K040210
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CX*RX25RW
• Device Lot Number: 211105
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/05/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 45 YR
• Patient Sex: Male
• Patient Weight: 68 KG