MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA CAPIOX FX15 OXYGENATOR; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number N/A

Device Problem Increase in Pressure (1491)

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

Event Date 12/23/2022

Event Type  malfunction  

Manufacturer Narrative

Implanted date: requested, not provided.Explanted date: requested, not provided.Occupation: clinical engineer.Pma/510(k): k071494, k130520.The actual sample was not returned to ashitala factory.The manufacturing record and the shipping inspection record of the actual product.No anomaly was found.No other similar report of the product with the involved product code/lot number was found.No anomaly was found in the manufacturing record of actual product.As a possible cause of occurrence, from information described in the reported issue, since the pressure gradually increased after the start of circulation, it was inferred that a blood-derived obstruction occurred in the oxygenator and the pressure increased.In addition, due to the generation of blood clots, the contact between blood and o2 gas was hindered, and the gas transfer performance was decreased, which reduced the amount of o2 supply relative to the patient's o2 consumption, and svo2 decreased and po2 decreased.However, since the actual product could not be confirmed, it was not possible to clarify the cause of this complaint.Relevant instructions for use (ifu) reference: do not reduce heparin during circulation.Otherwise, blood clotting might occur.(warnings): adequate heparinization of the blood is required to prevent it from clotting in the system.(warnings).Start gas supply with v/q=1, and fio2=100%, then make adjustments based on blood gas measurements.Measure blood gases and make necessary adjustments as follows.A) control pao2 by changing concentration of oxygen in ventilating gas using gas blender.To decrease pao2, decrease fio2.To increase pao2, increase fio2.B) control paco2 by changing the total gas flow.To decrease paco2, increase total gas flow.To increase paco2, decrease total gas flow.Terumo medical products (tmp) (importer) registration no: (b)(4) is submitting this report on behalf of ashitaka factory of (b)(4) corporation (manufacturer) registration no: (b)(4).

Event Description

The user facility reported that the involved device in a case of ventricular septal defect, when fx15 pre-connect circuit was used, pressure increased, and oxygenation failure occurred.Circulation was started around 11:30.Approximately thirty (30) minutes after the start of circulation, the pressure gradually increased.Approximately two (2) hours after the start (refer to chart data at 12:53), the pressure difference of pre oxygenator pressure and post oxygenator pressure was approximately 210.Po2 was approximately 110, the gas flow rate was approximately 1:1 with the pump flow rate, and fio2 was close to 100%.Although the pressure increasing and oxygenation worsened, since the end of operation was imminent, and the involved product was able to endure until the end, they continued using it.The operation completed successfully.The circuit was not replaced.The event occurred intra-operative.The producer outcome was completed successfully.The patient's final impact was not harmed.

• Brand Name: CAPIOX FX15 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: gina digioia ; 265 davidson ave; suite 320; somerset, NJ 08873 ; 6402040886
• MDR Report Key: 16238913
• MDR Text Key: 309300510
• Report Number: 9681834-2022-00279
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K071494
• 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: 01/25/2023

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: 01/31/2023
• Device Model Number: N/A
• Device Catalogue Number: CX-XRY50633A
• Device Lot Number: 210824
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/27/2022
• Initial Date FDA Received: 01/25/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/24/2021
• 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
• Treatment: BICARBON, VOLUVEN, HEPARIN AND MEYLON