MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA CAPIOX FX25 OXYGENATOR; OXYGENATOR, CARDIOPULMONARY BYPASS

Catalog Number CX-FX25E

Device Problem Increase in Pressure (1491)

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

Event Date 08/11/2022

Event Type  malfunction  

Event Description

The user facility reported that due to the pre oxygenator pressure increase to 450mmhg (flow rate 2l/min) of the capiox custom pack, preparations were made to replace the oxygenator.After, the pressure dropped to 250 mmhg (flow rate: 4.8 l/min).The device was replaced with an oxygenator unit fx25e.As a result, the pre oxygenator pressure became 300 mmhg at a flow rate of 4.8 l/min, which was higher than before the replacement.Afterwards, the pre oxygenator pressure did not decrease; however, the device was used until the end of pumping.There was no patient injury/medical or surgical intervention required.The procedure outcome was not reported.The final patient impact was not harmed.The event occurred intra-operative.

Manufacturer Narrative

Implanted date: device was not implanted.Explanted date: device was not explanted.Health professional: requested, unknown occupation - clinical engineer.Pma/510(k) - k130280.Visual inspection of the actual sample did not find any anomaly such as a breakage in its appearance.After the saline solution was flowed into the actual sample by a head, visual inspection of the gas transfer section was performed.As a result, the formation of blood clot was found; however, it was not possible to clarify the timing of the formation of this blood clot (e.G., at the time of use, or at the time of return).After the investigation, the actual sample was installed into a circuit consisting of tubes, and the pressure drop when circulating saline solution in the blood channel at each flow rate was measured.No significant difference was found compared to the current product.After filling the saline solution containing glutaraldehyde solution in the actual sample and fixing the blood clot found, the housing and filter were removed, and visual inspection of the gas transfer section was performed.No blood clot formation leading to increased pressure was found.No anomaly was found in the winding state of the fiber.After investigation of the actual sample, the fiber layer was removed, and visual inspection of the gas transfer section was performed.No blood clot formation leading to increased pressure was found.No anomaly was found in the winding state of the fiber.The outer cylinder was removed from the actual heat exchanger, and visual and magnifying inspections of the heat exchanger was performed.As a result, the formation of blood clot was found on the bottom surface.No anomaly such as a deformation of oxygenator that led to an obstruction was found.Electron microscopic inspection of the actual fiber found that blood cell components such as white blood cells and blood platelets had been adhered.Review of the manufacturing history 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, the pressure drop of the actual sample upon receipt was the same as the current product, and no obstruction was found.Although blood cell components such as blood platelets and white blood cells adhered to the fiber of actual sample, no blood clot formation leading to an increase in pressure was found.Therefore, it was not possible to clarify the cause of occurrence.Relevant 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)" (b)(4).

• 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: gina digioia ; reg. no. 2243441; 950 elkton blvd.; elkton, MD 21921 ; 6402040886
• MDR Report Key: 15380908
• MDR Text Key: 306268182
• Report Number: 9681834-2022-00175
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K071572
• 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: 09/08/2022

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 Catalogue Number: CX-FX25E
• Device Lot Number: 220310
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/12/2022
• Initial Date FDA Received: 09/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/10/2022
• 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