MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA CAPIOX FX25 OXYGENATOR; 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 05/23/2022

Event Type  Injury  

Manufacturer Narrative

Implanted date: device was not implanted.Explanted date: device was not explanted.Occupation - cardiovascular surgeon.Pma/510(k)- k130520.The actual device has not been returned for evaluation.The investigation is currently ongoing.A follow-up report will be submitted once the investigation is complete.A review of the manufacturing record and the shipping inspection record of the actual product confirmed that there were not any indications of anomaly in them.A search of the complaint file found no other similar report with the involved product code/lot number combination.(b)(4).

Event Description

The user facility reported air in the membrane of the capiox device involved.The patient had been in cec for roughly two minutes.When the perfusionist noticed the air, it was asked that the patient be removed from cec.After the patient was removed, the membrane was replaced.After the membrane was replaced, the surgery continued as normal without intercurrences.The event occurred intra-operative.There was no patient injury, medical or surgical intervention required.There was no harm to the patient.

Manufacturer Narrative

This report is being submitted as follow up no.1 to provide the device return date in section d9, update section h3, and to provide the completed investigation results.The actual sample was returned for investigation.Visual inspection of the actual sample did not find any anomaly including a breakage that could lead to the air mixing.After rinsing the actual sample, in order to confirm the filtering performance of the actual sample, bovine blood (temp.: 37°c, hb: 12g/dl) was circulated under the conditions of back pressure 200mmhg, flow rate of 2.3l/min, 4.7l/min, 7.0l/min respectively, and 30ml of air was inflowed from the gas inlet port side.No air outflow was found from the oxygenator through the filter.An arterial filter was connected to the blood outlet port side, and it was confirmed whether air was flowing out to the oxygenator and the arterial filter.Review of the manufacturing record and the shipping inspection record of the actual sample confirmed that there were not any indications of anomaly in them.A search of the complaint file found no other similar report with the involved product code/lot number combination.Based on the investigation result, no anomaly was found in the filtering performance test of actual sample.As a possible cause of this complaint, it was inferred that air flowed into the oxygenator for some reason, or air remained during priming.However, since no anomaly was found in the actual sample, it was not possible to clarify the cause of occurrence.Relevant instructions for use (ifu) reference: ·"ensure that the de-airing process is complete prior to initiating bypass (c.Initiation of bypass)" ·"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)" ·"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)" ·"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)".

• Brand Name: CAPIOX FX25 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: 14742422
• MDR Text Key: 295030894
• Report Number: 9681834-2022-00117
• Device Sequence Number: 1
• Product Code: DTZ
• UDI-Device Identifier: 04987350701022
• UDI-Public: 04987350701022
• Combination Product (y/n): N
• Reporter Country Code: AO
• 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,Followup
• Report Date: 06/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2023
• Device Model Number: N/A
• Device Catalogue Number: CX*FX25RE
• Device Lot Number: 200720
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/15/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/20/2020
• 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: 16 YR
• Patient Sex: Female
• Patient Weight: 59 KG