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 Known Impact Or Consequence To Patient (2692)

Event Date 04/27/2017

Event Type  Injury  

Manufacturer Narrative

Udi number not required for this product.The actual device was returned to the manufacturing facility for evaluation.Visual inspection revealed no obvious anomalies.Saline solution was drained through the blood phase by gravity.Subsequent visual inspection did not find any clot which was visible with the unaided eye.The actual device was fixed with glutaraldehyde solution.The housing and the filter were removed.Visual inspection of the filter did not find any clot which was visible with the unaided eye either on the outer or inner surfaces.The oxygenator module was visually inspected.There was no clot visible with the naked eye on the fiber surface.The fiber winding was confirmed to be in the normal state.The fiber layer was removed from the winding in increments of 2 mm and each layer was subjected to visual inspection.The closer the fiber layer came to the heat exchanger module, the more formation of red thrombus was found.The heat exchanger module, after all the fiber layers having been removed, was inspected with the unaided eye and under magnification.Clots were found to have formed on the bottom side.The outer and inner surfaces of the filter removed from the oxygenator module were subjected to magnifying inspections.Some clots were noted to have formed on them.There was no anomaly in the diameter of the filter mesh.The fiber layers removed from the oxygenator module were inspected under magnification.Some clots were found to have formed on the fiber layer located near the heat exchanger module.Electron microscopic inspection of the inside and outside surfaces of the filter revealed the adhesion of the blood corpuscle components consisting of red blood cells, white blood cells and blood platelets and the formation of the fibrin net.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 consisting of blood platelets, white blood cells, red blood cells and deformed red blood cells (echinocyte) and the formation of the fibrin net on the surface.The perfusion record was reviewed.After the first oxygenator was changed out to the second oxygenator (actual device), po2 and svo2 started to increase.After the change out to the device reported in the report the pressure before the oxygenator module started to increase.A review of the device history record of the involved product code/lot # combination was conducted with no relevant findings.There were two devices used in this event from the same product code/lot number combination.For the first device used see mdr 9681834-2017-00104.There is no evidence that this event was related to a device defect or malfunction.While the exact cause of the reported event cannot be definitively determined based on the available information, the following factors may have occurred simultaneously causing the reported event.The wet-lung phenomenon occurred, where water drops were accumulated in the fiber and this hampered blood from having sufficient contact with o2 gas and the gases from being transferred properly.Due to this, the volume of o2 supply became insufficient for the volume of the patient's o2 consumption, causing a decrease in svo2 and then in pao2.Clots started to form and hampered blood from having sufficient contact with o2 gas and the gases from being transferred properly.Due to this, the volume of o2 supply became insufficient for the volume of the patient's o2 consumption, causing a decrease in svo2 and then in pao2.The labeling does address the potential for such an event with the instruction-for-use (ifu) with statements such as the following: if water condensation and/or a decrease in pao2 and/or an increase in paco2 is noted during extended oxygenator use, briefly increasing the gas flow rate may improve the performance.Increase gas flow rate to 5l/min for 10 seconds.Do not repeat this flushing, even if oxygenator performance is not improved.(b)(4).All available information has been placed on file in quality assurance at the manufacturing facility for appropriate tracking, trending and follow-up.

Event Description

The user facility reported a pressure increase in the capiox device during a procedure.Follow up communication with the user facility confirmed the following information; during the operation, the pao2 value started to decrease; after a while, with no improvement in the pao2 value confirmed, the first oxygenator was changed out to another device from the same lot number (the device reported in this report); after the change out, with the second oxygenator, the pressure before the membrane started to increase again; and the rest of the procedure was able to be completed with the second oxygenator without another change out.

• 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: jennifer suh ; reg. no. 2243441; 2101 cottontail ln.; somerset, NJ 08873 ; 8002837866
• MDR Report Key: 6591123
• MDR Text Key: 75963779
• Report Number: 9681834-2017-00105
• 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: 05/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2019
• Device Catalogue Number: CX-FX05RW
• Device Lot Number: 161216
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/28/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/16/2016
• 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: SENKO MEDICAL OXYGENATOR TUBING PACK
• Patient Outcome(s): Other
• Patient Age: 9 MO
• Patient Weight: 7