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

Catalog Number CX*RX25RW

Device Problem Coagulation in Device or Device Ingredient (1096)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/03/2019

Event Type  malfunction  

Manufacturer Narrative

Implanted date: device was not implanted.Explanted date: device was not explanted.The actual sample was received for evaluation.Visual inspection upon received found the formation of clots inside the reservoir, on the outer surface of the venous filter, around the graduation of 300ml.Terumo's reservoir is designed to have the structure which allows the level of blood reserved in it to be better controlled.On the other hand, it is known that due to this structure, blood may not be able to be agitated well in the reservoir.To visualize the flow behavior in the actual reservoir sample, the following test was conducted: the actual sample was rinsed and dried.Saline solution was circulated in the actual sample at the flow rate of 4l/min.With the liquid level in the reservoir kept at 3000ml.During the circulation, 100ml of india ink was poured into the reservoir from one of the ports on the cardiotomy filter, while the flow behavior of the india ink was observed.The india ink was found to stagnate around the venous filter.The circulation conditions were set based on the provided images and perfusion record.Some images and movie showing the actual sample and the perfusion record from the involved procedure were also provided for review.In the images and movie, some clots are seen to have formed inside the reservoir of the actual sample, on the outer surface of the venous filter, around the graduations of 200 -500ml.Review of device history records and the shipping inspection record of the involved product/lot# combination was conducted with no relevant findings.Ifu states: do not reduce heparin during circulation.Otherwise blood clotting may occur.Adequate heparinization of the blood is required to prevent it from clotting in the system.Based on the provided information and investigation results, there is no definitive evidence that this event was related to a device defect or malfunction.Based on the investigation results, it is likely that the following factors could conspire to promote the clot formation in the actual sample.From the available information, it is difficult to determine the definitive cause.Terumo's reservoir is designed to have the structure which allows the level of blood reserved in it to be better controlled.On the other hand, it is known that due to this structure, blood may not be able to be agitated well in the reservoir.Blood in which coagulation factors had been activated was flowed into the reservoir and stagnated on the solution level, leading to the clot formation.However, the exact cause of the reported event cannot be definitively determined based on the available information.(b)(4).

Event Description

The user facility reported that a blood clot seen in the oxygenator's reservoir.The perfusionists have checked the act level quite usual and it is over 450, temperature management was ok and no blood transfusion during bypass surgery, the patient is not known heparin resistance.

• Brand Name: CAPIOX RX OXYGENATOR
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• Manufacturer (Section G): TERUMO CORPORATION, ASHITAKA; reg. no. 9681834; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• Manufacturer Contact: theresa mussaw ; reg. no. 2243441; 2101 cottontail ln.; somerset, NJ 08873 ; 8002837866
• MDR Report Key: 8850183
• MDR Text Key: 160049142
• Report Number: 9681834-2019-00136
• Device Sequence Number: 1
• Product Code: DTZ
• UDI-Device Identifier: 04987350769572
• UDI-Public: 04987350769572
• Combination Product (y/n): N
• PMA/PMN Number: K040210
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2021
• Device Catalogue Number: CX*RX25RW
• Device Lot Number: 181017K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/11/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/04/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/17/2018
• 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
• Patient Age: 22 YR
• Patient Weight: 57