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

Catalog Number CX-FX05RW

Device Problem Increase in Pressure (1491)

Patient Problem No Information (3190)

Event Date 10/31/2018

Event Type  Injury  

Manufacturer Narrative

Implanted date: device was not implanted.Explanted date: device was not explanted.510(k) no: k130280.The actual device was returned for evaluation.Visual inspection upon receipt revealed no anomaly, such as a break, in the appearance.The actual device was fixed with glutaraldehyde solution.The housing and filter were removed from the oxygenator module.Visual inspection of the filter did not reveal any clot formation visible to the unaided eye either on the outer or inner surface.Visual inspection of the oxygenator module, after the housing and filter having been removed from it, did not reveal any cot formation visible to the unaided eye on the fiber.The fiber winding was confirmed to be in the normal state.The fiber layer was removed from the winding in increments of 2mm and each layer was subjected to visual inspection.Some clots were found to have formed on the fiber layers located close to the heat exchanger module.The fiber and the outer cylinder were removed from the heat exchanger module and the inside of the heat exchanger module was subjected to visual and magnifying inspections.No clot formation was confirmed.The filter removed from the oxygenator module in the above inspection was inspected under magnification and revealed no clot formation.The diameter of the mesh of the filter was confirmed to be normal.The fiber layers removed during the above test were inspected under magnification.Some clots were found to have formed on the fiber layers located on 8mm from the outmost circumference to the last layer on the heat exchanger.The filter was inspected under electron microscope.The adhesion of the erythrocyte components, including platelets, were found on the surface.Electron microscopic inspection of the fiber on each layer on the upper side of the fiber winding obtained in above inspection revealed no clot formation which could have contributed to the pressure rise.A review of the device history record of the involved product code/lot number combination revealed no findings.There is no evidence that this event was related to a device defect or malfunction.During the inspection of the actual device, some platelets were found to be adhering to the oxygenator module.However, it cannot be determined if this has any cause-and-effect relationship with the reported complaint.The ifu states: "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." (b)(4).

Event Description

The user facility reported that soon after the initiation of the extracorporeal circulation, there was a rise in the pressure before the membrane was noted when using the involved capiox device.The pressure went up higher than the alarming value of 500 mmhg.The actual sample was changed out.Blood loss was reported to be 43 ml.The procedure outcome is unknown.The final patient impact is unknown.

• Brand Name: CAPIOX FX OXYGENATOR
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, shizuoka 418 ; JA 418
• Manufacturer (Section G): TERUMO CORPORATION, ASHITAKA; reg. no. 9681834; 150 maimaigi-cho; fujinomiya city, shizuoka 418 ; JA 418
• Manufacturer Contact: mark vornheder ; reg. no. 2243441; 950 elkton blvd; elkton, MD 21921
• MDR Report Key: 8077106
• MDR Text Key: 127340586
• Report Number: 9681834-2018-00204
• 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: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2021
• Device Catalogue Number: CX-FX05RW
• Device Lot Number: 180702
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/31/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/02/2018
• 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
• Patient Outcome(s): Other