MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA CAPIOX HOLLOW FIBER OXYGENATOR/ARTERIAL FILTER; OXYGENATOR, CARDIOPULMONARY BYPASS

Catalog Number CX-FX05RW

Device Problems Increase in Pressure (1491); Contamination /Decontamination Problem (2895)

Event Date 02/15/2022

Event Type  malfunction  

Manufacturer Narrative

Udi - n/a as this product code is not exported to the us market.Implanted date: device was not implanted.Explanted date: device was not explanted.Occupation- clinical engineer.Pma/510(k): k130280.The actual device has been returned for evaluation.Visual inspection of the actual sample upon receipt did not find any anomaly such as a breakage in its appearance.After the saline solution was flowed into the actual sample by a head, visual inspection of the gas transfer section was performed.As a result, the formation of blood clot was found.The "adhered substance of something like a yellow mass" described in the reported issue could not be found.After filling the saline solution containing glutaraldehyde solution in the actual sample and fixing, the housing and filter were removed, and visual inspection of the gas transfer section was performed.As a result, the formation of blood clot was found.No anomaly was found in the winding state of the fiber.After inspection of the actual sample 1.3, the fiber layer was removed, and visual inspection of the gas transfer section was performed.As a result, the formation of blood clot was found.No anomaly was found in the winding state of the fiber.The outer cylinder was removed from the actual heat exchanger, and visual and magnifying inspections of the heat exchanger was performed.As a result, the formation of white blood clot was found.No anomaly such as a deformation of oxygenator that led to an obstruction was found.Electron microscopic inspection of the actual fiber found that blood cell components such as blood platelets, white blood cells or red blood cells had been adhered and fibrin nets had been formed.The records at the time of use were confirmed.Following results were obtained: 1) platelet concentration was low during circulation.2) after the start of circulation at 13:20, when ivc blood removal was added at 13:23 and total run was performed at 13:25, each pressure increased sharply from each previous pressure measurement timing.Neither timing was the timing to lower the temperature of the blood.3) the pre oxygenator pressure decreased a little after peaking at 13:30.After that, it remained around 300 mmhg while following the blood flow.Review of the manufacturing history record and the product release decision control sheet of the actual sample confirmed that there were not any indications of anomaly in them.A search of the complaint file found no other similar report with the involved product code/lot number combination.Based on the investigation result, the formation of blood clot was found in the oxygenator.In addition, electron microscopic inspection of the actual fiber found that blood cell components such as blood platelets, white blood cells or red blood cells had been adhered and fibrin nets had been formed.As an occurrence factor of this complaint, from information that the formation of white blood cells by platelets was confirmed, and that the patient's platelet count decreased after surgery, it was likely that platelets aggregated for some reason, causing obstructing and increasing pre oxygenator pressure.However, it was not possible to clarify the cause of the formation of blood clot from the investigation of actual sample.Ifu states: 1) do not reduce heparin during circulation.Otherwise, blood clotting might occur.2) adequate heparinization of the blood is required to prevent it from clotting in the system.(b)(4).

Event Description

The user facility reported that immediately after the capiox fx05 pump was turned on, increasing of pre oxygenator pressure (350-400) was observed.After that, the oxygenator pressure returned to around 300, so it was handled while watching the situation as it was.After the operation, an adhered substance of something like a yellow mass, was seen on the oxygenator.The procedure outcome was not reported.The final patient impact was reported as not harmed.

Manufacturer Narrative

This report is being submitted as follow up no.1 to provide correction to section b4.The b4 date was inadvertently left blank.

• Brand Name: CAPIOX HOLLOW FIBER OXYGENATOR/ARTERIAL FILTER
• 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: stephanie handy ; reg. no. 2243441; 950 elkton blvd.; elkton, MD 21921 ; 9499890491
• MDR Report Key: 13769090
• MDR Text Key: 288047456
• Report Number: 9681834-2022-00027
• 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
• Reporter Occupation: Other Health Care Professional
• Report Date: 03/15/2022

1 Device was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CX-FX05RW
• Device Lot Number: 210916
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/15/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/16/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial