MAUDE Adverse Event Report: TERUMO MEDICAL CORPORATION CAPIOX FX 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 12/13/2023

Event Type  malfunction  

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 engineering.G4: pma/510(k): k130520.Investigation of the actual sample: visual inspection of the actual sample upon receipt no anomaly such as a breakage was found.The actual sample upon receipt was installed into a circuit consisting of tubes, and saline solution was circulated to measure the pressure drop.It was found that the pressure drop was high compared to the current product.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.Formation of blood clots was found.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.Formation of blood clots was found on the entire surface of the heat exchanger.Electron microscopic inspection of blood clots formed on the fiber and the heat exchanger was performed.Blood cell components such as red blood cells and deformed red blood cells (echinocytosis), as well as the formation of fibrin net, were found.Record review: the manufacturing record and the shipping inspection record of the actual sample no anomaly was found.Past complaint file no other similar report of the product with the involved product code/lot number was found.Cause of occurrence/conclusion: based on the investigation result, it was confirmed that the pressure drop of the actual sample upon receipt was high compared to the current product.In addition, formation of blood clots was found both on the fiber and the heat exchanger of the actual sample.However, the causal relationship between the formed blood clots and this event could not be clarified, and it was not possible to clarify the cause of occurrence.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.2243441 is submitting this report on behalf of ashitaka factory of terumo corporation (manufacturer) registration no.9681834.

Event Description

The user facility reported that an emergency coronary artery bypass graft (cabg) was performed for a patient in whom impella was introduced.Immediately after turning on the pump, the pre oxygenator pressure became 500 mmhg and the post oxygenator pressure became 400 mmhg, so the circuit was replaced.The circuit was replaced.The operation was completed without any problems.There was no harm to the patient.

• Brand Name: CAPIOX FX 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: 18461397
• MDR Text Key: 332733009
• Report Number: 9681834-2023-00272
• 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: 01/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: N/A
• Device Catalogue Number: CX-XRY05015A
• Device Lot Number: 230929
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/29/2023
• 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