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

Catalog Number CX-XRX51920

Device Problem Coagulation in Device or Device Ingredient (1096)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/12/2017

Event Type  malfunction  

Manufacturer Narrative

Pma/510(k): k130520.The actual device was returned for evaluation.Visual inspection upon receipt found the formation of aggregated red thrombus inside the cardiotomy filter component.It did not find any visible break on it.The cardiotomy filter component was taken out of the reservoir.Visual inspection of the filter and the defoamer set inside the filter found aggregated red thrombus forming on the inner and outer surfaces of the filter and on the inner surface of the defoamer.The venous filter component was taken out of the reservoir.Visual inspection of the filter and the defoamer set inside the filter did not find any aggregated red thrombus like the one found in the cardiotomy filter component.Electron microscopic evaluation of the filter of the cardiotomy filter component revealed the adhesion of red blood cells, deformed red blood cells (echinocytes) and the formation of fibrin net.Electron microscopic evaluation of the defoamer of the cardiotomy filter component, focusing on the segment where red thrombus had formed revealed the adhesion of red blood cells, deformed red blood cells (echinocytes) and the formation of fibrin net.There was no presence of red thrombus on the outer surface.Electron microscopic evaluation of the filter of the venous filter component revealed the adhesion of red blood cells and the formation of fibrin net.Electron microscopic evaluation of the defoamer of the venous filter component revealed no adhesion of red blood cells.A review of the device history record and shipping inspection record of the involved product code/lot number combination revealed no findings.Ifu reference: adequate heparinization of the blood is required to prevent it from clotting.Do not reduce heparin during circulation.Otherwise, blood clotting might occur.There is no evidence that this event was related to a device defect or malfunction.The exact cause of the reported event cannot be definitively determined based on the available information.(b)(4).

Event Description

The user facility reported clots with the capiox device.Follow up communication with the user facility confirmed the following information: during the operation, clots occurred inside the venous reservoir.The actual sample was not changed out and the operation was completed with it.The procedure was completed successfully.The patient was no 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: terry callahan ; reg. no. 2243441; 2101 cottontail ln.; somerset, NJ 08873 ; 8002837866
• MDR Report Key: 7174796
• MDR Text Key: 96727291
• Report Number: 9681834-2017-00253
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K071494
• 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: 01/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2019
• Device Catalogue Number: CX-XRX51920
• Device Lot Number: 171027
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/12/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/27/2017
• 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