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

Catalog Number CX-FX05E

Device Problem Increase in Pressure (1491)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/01/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(6).The actual device was returned to the manufacturing facility for evaluation.Visual inspection found no anomalies in the appearance.The actual sample, having been rinsed was subjected to another visual inspection.Residual blood was noted in the bottom side.The actual device was fixed with glutaraldehyde solution and the pressure drop was determined while water was circulated in the water pathway.The obtained values were found to meet manufacturing specification.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 visible clot formation was noted.After the filter had been removed from the oxygenator module, it was subjected to visual inspection.No visible clot formation was found.There was no anomalies in the state of fiber winding.The fiber layer was removed from the winding in increments of 4 mm.Each layer was subjected to visual inspection.No clot formation was revealed.The filter was subjected to magnifying inspection.No formation of clots was confirmed.No anomalies were noted in the outside diameters of the mesh.The fiber layers removed were inspected under magnification.Adhesion of blood cell components were found on the surface of the fibers.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 and fiber layers revealed the adhesion of the blood cell components, including platelets, white blood cells and red blood cells.Review of the perfusion record from the involved procedure suggests that a rise in the blood viscosity due to the increase in ht was not the cause of the increase in the pressure gradient.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 one other report with the involved product code/lot# combination from the same facility.See mdr 9681834-2016-00261.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 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: about an hour after initiation of circulation the pressure reached the max of 200 mmhg; the pressure came back to the normal value once, but later reached 200 mmhg; the procedure was completed successfully; and the patient was not harmed.

• 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: 6138075
• MDR Text Key: 61250279
• Report Number: 9681834-2016-00276
• 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: 12/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2016
• 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: 11/02/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/01/2016
• 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