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

Catalog Number CX-XRX47215

Device Problem Filtration Problem (2941)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/21/2017

Event Type  malfunction  

Manufacturer Narrative

Udi number for this product code is not required.The actual device has been returned to the manufacturing facility for evaluation.Visual inspection found no visible break on the device.Red thrombus was found to have formed inside the cr filter and the venous filter.The reservoir was disassembled for further inspection.Visual inspection of the cr filter and the de-foamer set inside the cr filter found the formation of red thrombus.The cr filter and the de-foamer were immersed in saline solution and fixed with glutaraldehyde.Subsequent visual inspection found the formation of red thrombus.Electron microscopic evaluation of the cr filter and the de-foamer, focusing on the segment where red thrombus had formed revealed the adhesion of red blood cells, deformed red blood cells (echinocyte) and the formation of fibrin net.Visual inspection of the venous filter and the de-foamer set inside the venous filter found white thrombus formed on the outer surface of the de-foamer.The venous filter and the de-foamer were immersed in saline solution and fixed with glutaraldehyde.Subsequent visual inspection found the formation of thrombus on the outer surface of the venous filter and on the outer surface of the de-foamer.Electron microscopic evaluation of the venous filter and the de-foamer, focusing on the segment where red thrombus had formed revealed the adhesion of red blood cells, deformed red blood cells (echinocyte) and the formation of fibrin net.A review of the device history record of the involved product code/lot number combination revealed no relevant findings.A search of the complaint file found no previous report of this nature with the involved product code/lot number combination.There is no evidence that this event was related to a device defect or malfunction.While the investigation confirmed the formation of red thrombus on the inside the cr filter of the actual reservoir the exact cause of the reported event cannot be definitively determined based on the available information.(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 clotting in the capiox device during a procedure.Follow up communication with the user facility confirmed the following information: after weaning out and administration of protamine (1/3 of the total volume), during sending back the blood to the patient thrombus formed over the cr filter; the filter became clogged; the operation was completed as intended; 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: terry callahan ; reg. no. 2243441; 2101 cottontail ln.; somerset, NJ 08873 ; 8002837866
• MDR Report Key: 6954704
• MDR Text Key: 90551153
• Report Number: 9681834-2017-00218
• 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: 10/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2018
• Device Catalogue Number: CX-XRX47215
• Device Lot Number: 170418
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/26/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/21/2017
• Initial Date FDA Received: 10/17/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/18/2017
• 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