MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA CAPIOX RX25 OXYGENATOR/RESERVOIR (LF PORT); OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number N/A

Device Problem Air/Gas in Device (4062)

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

Event Date 03/26/2022

Event Type  malfunction  

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.A detailed investigation could not be conducted because the actual sample was not returned.Ashitaka factory has experienced air inclusion in the oxygenator under the following conditions in the past: when the roller pump was suddenly stopped during priming, the pressure inside the oxygenator became negative and air was drawn through the fiber.Considering this, the simulation test using a sample from the same product code was performed as follows.Colored physiological saline solution was circulated at 4 l/min, which was the same flow rate as mentioned in the complaint, and then the roller pump was stopped suddenly.As a result, the pressure inside the oxygenator became negative (approx.20 mmhg, which was measured at the sampling line), and air inclusion occurred.(note: the negative pressure applied to the oxygenator when the roller pump is stopped suddenly varies depending on the circulatory conditions and circuit specifications.A review of the manufacturing record and product-release judgement record of the involved product code/lot number combination confirmed there was no indication of anomaly in them.A search of the complaint file found no other similar reports with the involved product code/lot number combination.Based on the provided additional information and the results of the simulation test, as one possible cause of this issue, it was inferred that the air was drawn in the oxygenator through the fiber due to the negative pressure generated inside the oxygenator when the roller pump was suddenly stopped.However, since the actual sample was not returned for analysis, the cause of occurrence could not be clarified.It was presumed that, when the roller pump was stopped suddenly or clamping operation was performed, though the inflow of the priming solution into the oxygenator stopped, the outflow from the oxygenator continued due to inertia, which resulted in the negative pressure inside the oxygenator.Relevant ifu reference: "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." "pressure in the blood phase should always be higher than that in the gas phase to prevent gaseous emboli entering the blood phase." (b)(4).

Event Description

The user facility reported that at the time of priming the oxygenator with crystolloid fluid, air bubbles were consistently seen over the membrane of the rx25 oxygenator.The air bubbles were seen after priming and recirculating the device for a significant amount of time.The bubbles were rising from the bottom of the oxygenator, travelling to the top, and eventually the bubbles entered the arterial line of the circuit.It was observed that the bubbles were formed when the pump was stopped abruptly.With gradual reduction of the pump speed, bubbles were not to be seen.The oxygenator was not replaced, and the procedure was continued as normal.No event was reported.The event had no impact on the functioning of the oxygenator throughout the procedure.The procedure outcome was not reported.The patient was no harmed.

• Brand Name: CAPIOX RX25 OXYGENATOR/RESERVOIR (LF PORT)
• 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: 14192943
• MDR Text Key: 290063024
• Report Number: 9681834-2022-00072
• 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: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: CX*RX25RW
• Device Lot Number: 210902
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/02/2021
• 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: 42 YR
• Patient Sex: Male
• Patient Weight: 55 KG