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

Catalog Number CX-XRY39501

Device Problem Increase in Pressure (1491)

Patient Problem Blood Loss (2597)

Event Date 12/07/2016

Event Type  Injury  

Manufacturer Narrative

This product code is not required to be registered with the fda. The actual device was returned to the manufacturing facility for evaluation. Visual inspection found no anomalies in the visual appearance. After having been fixed with glutaraldehyde solution, the device was further inspected with the unaided eye. A clot formation was found. Upon fixing treatment with glutaraldehyde solution, the flow of the solution was noted to be very slow. The housing and filter components were removed for visual inspection of the fibers. A clot formation was noted. There was no anomalies in the state of fiber winding. The fiber layer was removed from the winding in increments of 2 mm. Each layer was subjected to visual inspection. As the fiber layers were removed the clots became more noticeable. The heat exchanger module was inspected with the unaided eye and under magnification. White thrombus was found to have formed on the bottom and back sides. Magnifying inspection of the filter taken out of the oxygenator module revealed the clot formation on the surfaces. There was no anomalies in the diameter of the filter mesh. The fiber layers removed from the oxygenator module were inspected under magnification, clot formation was found. Electron microscopic inspection of the inside and outside surfaces of the filter revealed the formation of fibrin net and the adhesion of the erythrocyte components mainly consisting of blood platelets, white blood cells, red blood cells, and echinocytes. Electron microscopic inspection of the fiber on each layer on the upper side of the fiber winding revealed the formation of fibrin net and the adhesion of the erythrocyte components mainly consisting of blood platelets, white blood cells, red blood cells, and echinocytes. A review of the device history record 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# combination. There is no evidence that this event was related to a device defect or malfunction. Although an exact cause cannot be definitively determined based on the investigation results, it is likely that some clots formed due to some factors, resulting in the reported increase in the pressure. 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: recirculation was ongoing during the preparation of the oxygenator; to implement cannulation, heparin was administered; with no increase in act to the desirable value, another heparin was added; act was increased enough to start suctioning blood; at this stage, only the suctioned blood was being circulated inside the oxygenator; the pressure before the oxygenator started to rise; the extracorporeal circulation started; the flow rate would not reach the appropriate level, it was around 500 ml/min. @2000 rpm; the customer determined the oxygenator was obstructed and changed out to another one; blood loss was 200 ml; after this, no further issues occurred; and the patient recovered.

• 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: 6194921
• MDR Text Key: 63058466
• Report Number: 9681834-2016-00299
• 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

• Type of Report: Initial
• Report Date: 12/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 11/30/2017
• Device Catalogue Number: CX-XRY39501
• Device Lot Number: 160602
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2016
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 12/08/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/02/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 12/21/2016 Patient Sequence Number: 1

Treatment

ALBUMIN; CV-510H1 LOT# 160808; CX-XPU39501 LOT# 160810; HEPARIN 5CC; SOLULACT