MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA CAPIOX FX15; OXYGENATOR, CARDIOPULMONARY BYPASS

Catalog Number CX-FX15RW40V

Device Problem Increase in Pressure (1491)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/15/2019

Event Type  malfunction  

Manufacturer Narrative

Udi - not required for product code.Implanted date: device was not implanted.Explanted date: device was not explanted.Pma/510(k)- k130520.The actual sample was received for evaluation.Visual inspection revealed that red clots and white clots had formed.Blood observed on the back and bottom sides of the oxygenator was conceivable to be the result that the blood cell components that had been accumulated between the housing and the fiber of the oxygenator became precipitated during the return shipment to (b)(6).An attempt was made to irrigate the blood channel with saline solution by gravity drop, however, the flow rate of over 0.1ml/min could not be obtained.Based on this, it is presumed that the actual device had been clogged.The inside of the oxygenation module was fixed by being filled with glutaraldehyde-containing saline solution.Then, the housing and the filter were removed and subjected to visual inspection.Formation of blood clots were found on the outer and inner surfaces of the filter.No clots were found to have formed inside the housing.The oxygenation module was visually inspected, and some blood clots were found to have formed.The state of the fiber winding was confirmed to be normal.The fiber layers were removed from the winding in increments of 2mm and each layer was subjected to visual inspection.Blood clots were found to have formed in all layer.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.Red clots were found to have formed.The filter that had been removed was inspected under magnification.Red and white clots were found to have formed on both the outer and the inner surfaces.The fiber layers removed during the test were inspected under magnification.Red and white clots were found to have formed.Electron microscopic inspection of the filter found the aggregations of platelets, adhesion of blood cell components such as deformed red blood cells (echinocyte), and formation of fibrin nets on both the outer and the inner surfaces of the filter.Electron microscopic inspection of the fiber layers found the aggregations of platelets, adhesion of blood cell components such as red blood cells, deformed red blood cells (echinocyte), and formation of fibrin nets on all layer.Electron microscopic inspection of the white clot formed on the upper side of the oxygenator found the aggregations of platelets, fibrin nets, and adhesion of blood cell components such as deformed red blood cells (echinocyte).The clots adhering to the heat exchanger module was collected and inspected under electron microscope.The blood cell components such as red blood cells were observed.A review of the device history record and product release decision control sheet of the involved product code/lot number 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 the clots were formed due to some factors and caused the pressure inside the oxygenator to increase; however, from the available information, it is difficult to determine the factors that caused the formation of clots.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 involved capiox device was used during a taa case.After ten minutes from the start of cpb, the pressure inside the oxygenator was found to have increased from 200mmhg to 450mmhg.When the rectal temperature was decreased from 35°c to 20°c, the pressure inside the oxygenator did not change and some white substances appeared inside (upper part) of the oxygenator.Afterward, from when rewarming started, the pressure decreased gradually.There was no change out of the oxygenator.There was no harm to the patient.The procedure outcome was not reported.

• Brand Name: CAPIOX FX15
• 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
• MDR Report Key: 9409722
• MDR Text Key: 204009898
• Report Number: 9681834-2019-00209
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: ID
• 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: 12/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2022
• Device Catalogue Number: CX-FX15RW40V
• Device Lot Number: 190823
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/15/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/23/2019
• 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