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

Catalog Number CX-FX25E

Device Problem Increase in Pressure (1491)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/07/2019

Event Type  malfunction  

Manufacturer Narrative

Udi - not required for product code.Implanted date: device was not implanted.Explanted date: device was not explanted.510(k): k130520.The actual sample was returned for evaluation.Visual inspection revealed no anomalies, such as a break, in the visual appearance.Saline solution was let to flow through the actual device by gravity.Subsequent another visual inspection did not find any clot formation visible with the naked eye.The actual device was built into a circuit with tubes.Saline solution was circulated in it and the pressure drop was determined at each flow rate.The pressure drop was found to be equivalent to than that of the current product sample.The actual device was filled with saline solution containing glutaraldehyde solution to be fixed and the housing component and filter were removed.Visual inspection of the outer and inner surfaces of the filter did not find any clot formation visible with the naked eye.Visual inspection of the oxygenator module did not find any clot formation visible with the naked eye.The state of the fiber winding was confirmed to be normal.The fiber layer was removed from the winding in increments of 2mm and each layer was subjected to visual inspection.There was no clot formation on the fiber layers visible with the naked eye.The outer cylinder was removed from the heat exchanger module and the inside of the heat exchanger module was subjected to visual and magnifying inspections.There was no clot formation on it.The outer and inner surfaces of the filter that were removed, were inspected under magnification.There was no clot formation on them.The diameters of the mesh were confirmed to be normal.The fiber layers that were removed, were inspected under magnification.There was no clot formation on them.Electron microscopic inspection of the outer and inner surfaces of the filter revealed the adhesion and agglutination of the blood corpuscle components, including blood platelets.Electron microscopic inspection of the fiber on each layer on the upper side of the fiber winding revealed the adhesion of the blood corpuscle components, including blood platelets, red blood cells and white blood cells, in a slight amount.There was no clot formation which could have be a trigger of a pressure rise.A review of the device history record and product release decision control sheet of the product code/lot# combination was conducted with no findings.Based on the provided information and investigation results, there is no definitive evidence that this event was related to a device defect or malfunction.The investigation results verified the returned sample was of the normal product.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 at the beginning of use of the capiox device, the pressure at the inlet port started to rise gradually up to 450mmhg at the maximum.With no further rise seen in the pressure, the customer continued to use the actual sample until the end of the surgery.The patient was not harmed.

• 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; 950 elkton blvd; elkton, MD 21921 ; 8002837866
• MDR Report Key: 8959588
• MDR Text Key: 157867822
• Report Number: 9681834-2019-00153
• 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: 09/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2022
• Device Catalogue Number: CX-FX25E
• Device Lot Number: 190402
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/07/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/02/2019
• 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