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 03/24/2022

Event Type  malfunction  

Event Description

The user facility reported that at the time of priming 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, they couldn't find any visible crack or any leakage on the oxygenator.There was no patient involvement when the event occured.The event occurred pre-treatment.Additional was received on 11 april 2022: yes, the roller pump was used to the bcp port.The flow rate of cardioplegia pump was around 150-250ml/min.The type of pump in the main circuit was a roller pump, and the flow rate during priming was 3-4 lpm.The pump was abruptly stopped during priming with the control knob while clamping the arterial line to check the occlusion and just before the line were divided on the surgical area for cannulation.No gas blowing was performed.The was not stopped abruptly.It's a part of protocol done while clamping the venous or arterial line to check the occlusion or if it happens due to high pressure more than set limit.It was reported that they were unaware that negative pressure is generated in the oxygenator when the pump stops abruptly.

Manufacturer Narrative

Implanted date: device was not implanted.Explanted date: device was not explanted.The actual device has not returned for evaluation.The investigation is currently ongoing.A follow up report will be submitted once the investigation is complete.Review of the manufacturing record and the product release judgement record of the involved product/lot# combination confirmed there was no indication of anomaly in them.A search of the complaint file found two similar reports (tipl-013-2022 and tipl-012-2022) with the involved product code/lot# combination from the same facility.In these two cases, no anomaly was noted in the manufacturing records, it was concluded that there was no problem with the involved products.(b)(4).

Manufacturer Narrative

This report is being submitted as follow-up no.1 to provide the completed investigation results.The actual device was not returned; therefore, an evaluation of the actual device was unable to be conducted.Based on the investigation result, no anomaly was found in the manufacturing history record and the shipping inspection record.As an occurrence situation in this case, there was information that air contamination occurred when the pump was suddenly stopped.Therefore, as the cause of the occurrence, it was conceivable that when the pump was suddenly stopped, the inside of the oxygenator became negative pressure and air was drawn in through the fiber.Since the actual sample was not returned, however, analysis of it could not be performed, the cause of occurrence could not be clarified.Relevant ifu (instructions for use) reference: do not obstruct gas outlet port.Avoid buildup of excess pressure in the gas phase to prevent gaseous emboli entering the blood phase.(warnings).Pressure in the blood phase should always be higher than that in the gas phase to prevent gaseous emboli entering the blood phase.(warnings).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).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).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).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).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).Ensure that the de-airing process is complete prior to initiating bypass.(c.Initiation of bypass caution).

• 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: 14163448
• MDR Text Key: 289963610
• Report Number: 9681834-2022-00064
• 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,Followup
• Report Date: 04/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2022
• 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?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/14/2022
• Was Device Evaluated by Manufacturer?: No
• 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: 63 YR
• Patient Sex: Male
• Patient Weight: 71 KG