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

Catalog Number CX*FX25RW

Device Problem Obstruction of Flow (2423)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 03/04/2022

Event Type  Injury  

Manufacturer Narrative

Implanted date: device was not implanted.Explanted date: device was not explanted.Occupation - requested, others.Pma/510(k)- k130520.(b)(4).The actual sample was not returned therefore a detailed investigation could not be performed.The provided photos were confirmed.Following results were obtained: (i) there were blood clots in the lower part of hard-shell reservoir; (ii) there were blood clots in the gas exchange module of oxygenator.Since no event such as gas transfer failure or increasing of pressure was confirmed, it was inferred that the blood clots seen in the oxygenator was formed after the procedure.Review of the manufacturing 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# combination.Since the investigation of actual product could not be performed, the cause of occurrence could not be clarified.Our reservoir is structurally designed to stabilize the blood storage surface to make it easier to manage the blood storage surface.On the other hand, it has the characteristic that the blood in the reservoir is not easily agitated.Therefore, based on its characteristics and our past experience, as a cause of forming blood clots, it was likely that blood that was agitated with air by suction and whose coagulation factor was activated flowed into the reservoir and stayed on the blood storage surface.Then, when the blood storage surface level was lowered, the formation of blood clots was noticed.Relevant ifu reference: "adequate heparinization of the blood is required to prevent it from clotting in the system.(warnings)" "do not reduce heparin during circulation.Otherwise, blood clotting might occur.(warnings)." (b)(4).

Event Description

The user facility reported that post tavr valve surgery, coming off bypass 30 minutes after a clot formed in the involved capiox device reservoir.Due to the continuous bleeding, volume was given as per the requirement of cvp and the patient's hemodynamics.The clot was in the deforming chamber.The oxygenator was precautionary changed while the patient was still cannulated.Medical or surgical intervention was not required to prevent patient injury.The patient's current condition was not harmed.

• Brand Name: CAPIOX FX25 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: stephanie handy ; reg. no. 2243441; 950 elkton blvd.; elkton, MD 21921 ; 9499890491
• MDR Report Key: 13970088
• MDR Text Key: 288479002
• Report Number: 9681834-2022-00054
• Device Sequence Number: 1
• Product Code: DTZ
• UDI-Device Identifier: 04987350701046
• UDI-Public: 04987350701046
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K071494
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CX*FX25RW
• Device Lot Number: 210713
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/05/2022
• Initial Date FDA Received: 03/31/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/13/2021
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 77 YR
• Patient Sex: Female
• Patient Weight: 75 KG