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

Model Number N/A

Device Problem Obstruction of Flow (2423)

Patient Problem Insufficient Information (4580)

Event Date 10/31/2023

Event Type  Injury  

Manufacturer Narrative

A1: patient identifier: requested, not provided a2: age & date of birth: requested, not provided a3: patient sex: requested, not provided a4: weight: requested, not provided a5: ethnicity: requested, not provided a6: race: requested, not provided d4: udi: n/a as this product code is not exported to the us market.D6a: implanted date: device was not implanted d6b: explanted date: device was not explanted e3: occupation: clinical engineer g4: pma/510(k): k130520 an oxygenator and a reservoir were returned for product investigation.Inspection of the oxygenator obtained the following results.Visual inspection of the actual sample upon receipt found no anomaly such as a breakage.The actual sample was filled with glutaraldehyde-containing saline solution and fixed, the housing and filter were removed, and visual inspection of the gas transfer part was performed.No anomaly was found in the condition of fiber winding.The fiber layer was removed gradually, and visual inspection of the gas transfer part was performed.No anomaly was found in the condition of fiber winding.The outer cylinder was removed from the heat exchanger, and visual and magnifying inspections of the heat exchanger were performed.There were no anomalies such as deformation of the heat exchanger.Inspection of the reservoir obtained the following results.Visual inspection of the actual sample upon receipt found no anomaly such as a breakage.The reservoir was disassembled for the visual inspection of the venous filter, cr filter, and the defoamers inside.The formation of blood clots was observed in the cr filter and its defoamer.It was reported that circulation was resumed after scp; however, as the flow rate was recorded as zero in the pump record, it was not possible to clarify how the flow rate decreased.No anomaly was found in the manufacturing record and the shipping inspection record.No other similar report was found in the past complaint file.It was likely that an obstruction occurred inside the oxygenator for some reason.However, since the actual sample had been rinsed off with water when received, it was not possible to clarify the factors that caused the obstruction.Relevant instructions for use (ifu) reference: "do not reduce heparin during circulation.Otherwise, blood clotting might occur." "adequate heparinization of the blood is required to prevent it from clotting in the system." terumo medical products (tmp) (importer) registration no.(b)(4) is submitting this report on behalf of ashitaka factory of terumo corporation (manufacturer) registration no.(b)(4).

Event Description

The user facility reported that on (b)(6) 2023 a fourth redo total arch replacement was performed.According to the pump record, cardiopulmonary bypass started at 12:00.After circulating with scp only, an attempt was made to restart blood supply to the lower extremities at 17:00; however, blood could not be delivered, and cold aggregation was suspected.Since no delivery could be achieved, the arterial line was clamped; however, a large amount of air was drawn into the scp side, and the entire circuit had to be replaced.Based on the pump record and circumstances, it was assumed that coagulation occurred in the reservoir during scp, and the oxygenator became clogged when the flow was increased to resume blood flow to the lower extremities.It took fifteen (15) minutes to replace the entire circuit, accordingly it took some time before blood could be delivered to the lower extremities.The patient was intubated, and health hazard to the patient has not been confirmed yet.This event was related to a blood clot and blockage, and the product containing the patient's blood was changed out.The procedure outcome was not reported.The event occurred intra-operative.The final patient impact was unknown.

• Brand Name: CAPIOX OXYGENATOR
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): TERUMO MEDICAL CORPORATION; 950 elkton blvd.; elkton MD 21921
• 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 ; 4103927218
• MDR Report Key: 18235829
• MDR Text Key: 329315458
• Report Number: 9681834-2023-00241
• 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: 11/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: N/A
• Device Catalogue Number: CX-XRY21905A
• Device Lot Number: 230615
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/15/2023
• 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: CDI500
• Patient Outcome(s): Other; Required Intervention