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

Catalog Number CX-FX05RE

Device Problem Pressure Problem (3012)

Patient Problems No Consequences Or Impact To Patient (2199); Blood Loss (2597)

Event Date 10/31/2017

Event Type  Injury  

Manufacturer Narrative

The actual device was returned for evaluation.Visual inspection of the actual sample upon receipt revealed no defects.The pressure drop was determined by saline solution being circulated in the blood pathway at each flow rate.The pressure drop was found to be higher than that determined on the current product sample.The oxygenator module was fixed with glutaraldehyde solution and subjected to another visual inspection.The presence of clots was found inside the device.The housing component and filter were removed from it.Visual inspection of the filter found the presence of clots on the both sides.Visual inspection of the oxygenator module found the presence of clots on the fiber.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.The presence of clots was found on each 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 and white thrombi were found to have formed on and between the grooves.Magnifying inspection of the outer and inner surfaces of the filter found the formation of red thrombus on both surfaces.The state of the meshes, including the diameter, was confirmed to be normal.The fiber layers collected during the above inspection was inspected under magnification.The formation of red thrombus was found on each layer.Electron microscopic inspection of the filter revealed the formation of fibrin net and the adhesion of the blood cell components, including red blood cells, deformed red blood cells (echinocyte) and white blood cells, on the both sides.Electron microscopic inspection of the fiber on each layer on the upper side of the fiber winding removed from the oxygenator module above revealed the formation of fibrin net and the adhesion of blood cell components, including red blood cells, deformed red blood cells (echinocyte) and white blood cells.The red thrombus adhering to the heat exchanger module was collected and inspected under electron microscope.The formation of fibrin net and the adhesion of blood cell components, including deformed red blood cells (echinocyte) and white blood cells were revealed.A review of the device history record of the involved product code/lot number combination revealed no findings.A search of the complaint file found no previous report of this nature with the involved product code/lot number combination.During the evaluation of the actual sample, the formation of thrombus was found on the filter, fiber, and on the heat exchanger module.Electron microscopic inspection of the red thrombus revealed the presence of the fibrin net and the blood cell components, including red blood cells, deformed red blood cells (echinocyte), and white blood cells.There is no evidence that this event was related to a device defect or malfunction.Although the exact cause of the reported event cannot be definitively determined based on the available information, it is likely that thrombus formed inside the oxygenator module of the actual sample due to some factor(s) led to the reported rise in the pressure inside the oxygenator module.From the available information, however, it is difficult to determine the cause of the formation of thrombus.The device labeling does address the potential for such an event in the instructions-for-use (ifu) with statements such as the following: 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 an increase in the pressure drop in the capiox device during a procedure.Follow up communication with the user facility confirmed the following information: priming was done in the normal manner for 5 - 10 minutes.After starting the circulation, the pressure started to rise, finally up to 400mmhg.It was reported that to avoid any adverse event that once the circulation stopped the actual sample was changed out.Blood loss was reported to be unknown.The operation was completed successfully and there was no harm to the patient's health.

• 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: terry callahan ; reg. no. 2243441; 2101 cottontail ln.; somerset, NJ 08873 ; 8002837866
• MDR Report Key: 7066252
• MDR Text Key: 93162222
• Report Number: 9681834-2017-00243
• 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
• Type of Report: Initial
• Report Date: 11/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2020
• Device Catalogue Number: CX-FX05RE
• Device Lot Number: 170510
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/01/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/10/2017
• 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
• Treatment: CDI500(TCVS); HAS2(SENKO)
• Patient Outcome(s): Other