MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA CAPIOX RX25 OXYGENATOR/RESERVOIR (LF PORT); 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 03/31/2022

Event Type  malfunction  

Manufacturer Narrative

Implanted date: device was not implanted.Explanted date: device was not explanted.The actual device was not returned for evaluation.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 (approximal 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.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 (instructions for use) 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 crystalloid fluid, the air bubbles were consistently seen over the membrane of the rx25 oxygenator even after priming and recirculating it for the significant time.The bubbles kept arising from the bottom of the oxy travelling to the top and eventually entering the arterial line of the circuit.However, it was observed that the bubbles were formed when the pump was stopped abruptly and 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.The event had no impact on the functioning of the oxygenator throughout the procedure.There was no patient involvement when the event occurred.The event occurred pre-treatment.The patient's final impact was not 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: 14205194
• MDR Text Key: 290062785
• Report Number: 9681834-2022-00071
• 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,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2022
• 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: 211029
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/31/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/29/2021
• 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: 37 YR
• Patient Sex: Male
• Patient Weight: 66 KG