MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA CAPIOX FX25; OXYGENATOR, CARDIOPULMONARY BYPASS

Catalog Number CX-XRX43502

Device Problems Coagulation in Device or Device Ingredient (1096); Infusion or Flow Problem (2964)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/28/2021

Event Type  malfunction  

Manufacturer Narrative

Udi: not required for product code.Implanted date: device was not implanted.Explanted date: device was not explanted.Occupation: clinical engineer.Pma/510(k)- k130520.A picture and the actual sample were provided by the user facility.The provided picture showed that the blood level in the reservoir was around 1000 ml, while the venous filter stained red by blood up to the upper part.Blood clots were observed in a part of the housing.Visual inspection of the actual sample revealed no damage or other external anomaly.Blood was found adhering to a part of the housing.The venous filter and the defoamer of the venous filter were soaked in normal saline, and then subjected to visual inspection.Blood clots had formed on the upper part of the inner surface of the venous filter and the outer surface of the defoamer.No formation of blood clots was observed in the lower part of the inside of the venous filter.The venous filter was soaked in physiological saline solution, and then subjected to visual inspection.Blood clots were found on the upper part of the inner surface.The defoamer in the venous filter was soaked in physiological saline solution, and then subjected to visual inspection.Blood clots were found on the outer surface.There was no formation of blood clots that could lead to blockage on the lower part inside the venous filter.The venous filter and the defoamer were fixed with physiological saline solution containing a glutaraldehyde solution, and then inspected under electron microscope.Adhesion of blood cell components such as red blood cells and platelets and formation of fibrin net were observed.There was no formation of blood clots that could lead to blockage on the lower part inside the venous filter.A part of the venous filter was cleaned, and then inspected under electron microscope.No anomaly was observed in the filter condition, such as uneven mesh diameter.Reproductive testing was performed, and bovine blood was circulated in the manner that air continued entering the venous line.As a result, it was confirmed that blood flowed out from the upper part of the venous filter.The air entering the venous filter is defoamed by the defoamer in the venous line in the normal condition.The reproductive test showed that, as the air continued entering the venous line, the defoamed blood flowed out from the upper part of the venous filter.A review of the device history record and product-release judgement record of the involved product code/lot# combination was conducted with no findings.Based on the provided information and investigation results, there is no definitive evidence that this event was related to a device defect or malfunction.It is likely that air continued to be drawn from the venous line, causing fluid to flow out from the upper side of the venous filter.In addition, it was conceivable that the air bubbles entered the venous filter may have agitated the blood activating the coagulation factors, which led to the formation of blood clots in the housing.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 the capiox device was used during the procedure.The patient underwent mvp/tap/maze mics.Air from venous line was observed immediately after the start of extracorporeal circulation, although it disappeared soon.About ten minutes after the start of ecc, a holdup phenomenon occurred on the venous side of the reservoir.The reservoir level was 1000 ml, and the fluid was lifted up to the position of defoamer at 3500ml.There was no problem with the oxygenator pressure or the filter on the cr side.After that, when the fluid level moved, blood clots were observed on the fluid surface.They maintained the circulation without changing the level and prevented air entering from venous line.Once rewarming started from 32°c, the holdup phenomenon disappeared and the ecc was completed without any problem.After collecting blood, blood clots were found in the reservoir.The procedure outcome was not reported.The patient was not harmed.

• Brand Name: CAPIOX FX25
• 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: mary o'neill ; reg. no. 2243441; 265 davidson ave suite 320; somerset, NJ 08873 ; 8002837866
• MDR Report Key: 11884144
• MDR Text Key: 265198218
• Report Number: 9681834-2021-00086
• 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 Health Care Professional
• Type of Report: Initial
• Report Date: 05/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2022
• Device Catalogue Number: CX-XRX43502
• Device Lot Number: 210129
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/01/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/28/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/29/2021
• 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