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

Catalog Number CX-XRX53402A

Device Problem Increase in Pressure (1491)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/28/2019

Event Type  malfunction  

Manufacturer Narrative

Implanted date: device was not implanted.Explanted date: device was not explanted.The 510k - k130520.The actual device was received for evaluation.Visual inspection with the naked eye revealed no obvious anomaly.Saline solution was let to flow through the inside of the actual device by gravity.Subsequent visual inspection of the gas transfer module found it had been discolored into pale brown.The actual device was built into a circuit with tubes and the pressure drop during circulation of saline solution at each flow rate.The obtained values were confirmed to be equivalent to those of the current product sample.The saline solution coming out of the actual device was found to have become cloudy.The actual device was filled and fixed with saline solution containing glutaraldehyde solution for further inspection.The filter was removed from the actual device for further visual inspection.It was found to have been discolored faintly on both surfaces entirely.Visual inspection of the actual device, after the housing component and the filter having been removed from it, found the fiber had been faintly discolored entirely.There was no anomaly in the state of fiber winding.The fiber layers were removed from the winding in increments of 2 mm and each layer was subjected to visual inspection.After 2mm was removed; there was no clot visible to the naked eye, after 4mm was removed; there was no clot visible to the naked eye, after 6mm was removed; there was no clot visible to the naked eye, after 8mm was removed; there was no clot visible to the naked eye, after 10mm was removed; there was no clot visible to the naked eye, after 12mm was removed; there was no clot visible to the naked eye, and after 14mm was removed; there was no clot visible to the naked eye.The outer cylinder was removed, and the heat exchanger module was subjected to visual and magnifying inspections; no clot was found.Magnifying inspection of both surfaces of the filter removed from the actual device did not find any clot on either surface.Magnifying inspection of the fiber layers removed from the oxygenator module in revealed the formation of white thrombus partially on the fiber.Electron microscopic inspection of the outer and inner surfaces of the filter removed from the actual device revealed adhesion and aggregation of blood corpuscle components, including blood platelets and white blood cells on them.Electron microscopic inspection of the upper sections of the fiber layers removed from the oxygenator module revealed adhesion of blood corpuscle components, including white blood cells and a large amount of blood platelets, to them.A review of the device history record and product release decision control sheet of the product code/lot# combination was conducted with no findings.Ifu states: adequate heparinization of the blood is required to prevent it from clotting in the system.Do not reduce heparin during circulation.Otherwise, blood clotting might occur.Based on the provided information and investigation results, there is no definitive evidence that this event was related to a device defect or malfunction.It is likely that white thrombus was formed inside the actual device due to some factor(s), resulting in the reported pressure rise during the circulation.However, the exact cause of the reported event cannot be definitively determined based on the available information.(b)(4).

Event Description

The user facility reported that the actual capiox custom pack was used for an arch aortic replacement.During the circulation, the pressure became high.After the operation, a decrease in the number of blood platelets was noted.The oxygenator was not changed out.The patient was not harmed, the procedure outcome was not provided.

• Brand Name: CAPIOX FX 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: theresa mussaw ; reg. no. 2243441; 2101 cottontail ln.; somerset, NJ 08873 ; 8002837866
• MDR Report Key: 8806999
• MDR Text Key: 151599622
• Report Number: 9681834-2019-00127
• 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: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2020
• Device Catalogue Number: CX-XRX53402A
• Device Lot Number: 190328
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/04/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/28/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/28/2019
• 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