MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA CAPIOX HOLLOW FIBER OXYGENATOR/ARTERIAL FILTER; OXYGENATOR, CARDIOPULMONARY BYPASS

Catalog Number CX-FX05E

Device Problem Increase in Pressure (1491)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/27/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(6).The actual device was returned to the manufacturing facility for evaluation.Visual inspection upon receipt revealed no anomalies or defects.The actual sample, after the blood pathway was rinsed with 500ml of saline solution, was subjected to another visual inspection.No clot formation was observed.The actual device was fixed with glutaraldehyde solution and the housing component was removed for further inspection of the inside of the oxygenator module.The filter was removed and the outer and inner surfaces were subjected to visual inspection.No clot formation was observed.After the filter had been removed, the oxygenator module was subjected to visual inspection.No clot formation was observed and there was no anomaly in the state of fiber winding.The fiber layer was removed from the winding in increments of 4mm and each layer was subjected to visual inspection.No clot formation was observed.Magnification inspection of the filter revealed no clot formation on either of the surfaces and there was no anomaly on the outside diameters of the mesh.Magnification of the fiber layers revealed adhesion of blood cell components on the surface of the fibers.After the outer cylinder was removed, the heat exchanger module was inspected with the naked eye and under magnification.The formation of white thrombus was revealed.Electron microscopic inspection of the outer and inner surfaces of the filter revealed the adhesion of the blood cell components, including platelets, white blood cells and red blood cells.Electron microscopic inspection of the fiber layer revealed blood cell components, including platelets, white blood cells and red blood cells.A review of the device history records and the product release decision control sheet of the involved product code/lot number combination was conducted with no relevant findings.A search of the complaint file found no other report with the involved product code/lot number combination.There is no evidence that this event was related to a device defect or malfunction.Although the exact cause cannot be definitively determined based on the investigation results, it is likely that the blood components such as platelets was activated to aggregate easily due to some changes in the blood property, causing the heat exchanger module to become obstructed, resulting in the increase in the pressure drop.The device labeling does address the potential for such an occurrence in the instruction for use (ifu) with the statement such as the following: "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." (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 when using the capiox device.Follow up communication with the user facility confirmed the following information: for five minutes after the initiation of the circulation the pressure was on the normal level.Forty minutes later, the pressure gradient was increased up to maximum 194mmhg.It was reported as it was decreased moderately after the rewarming, the circulation was continued without change-out of the device.It was reported that the patient was not harmed.

• Brand Name: CAPIOX HOLLOW FIBER OXYGENATOR/ARTERIAL FILTER
• 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: 6114059
• MDR Text Key: 60449962
• Report Number: 9681834-2016-00261
• 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: 11/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2019
• Device Catalogue Number: CX-FX05E
• Device Lot Number: 160610
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/27/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/10/2016
• 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: S5(HLM)