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

Model Number	N/A
Medical Device Problem Code	Increase in Pressure (1491)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/06/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The user facility reported that due to a high pressure drop of the oxygenating chamber of another company, after 100 minutes of cec, the device was replaced with an oxygenating chamber fx25w.After 40 minutes of the replacement, there was a new pressure increase entering the oxygenator up to a value of about 515 mmhg after about 90 minutes; at this point the customer opts for a third change of oxygenating chamber by mounting an additional fx25w with which he concludes the intervention.Act values have always remained within the physiological ranges for extracorporeal circulation.The procedure performed was mitralic valve replacement and aorto-coronary bypass graft.This caused a delay in the surgical procedure.The surgery was completed successfully, however, the patient was in the operating room (o.R.) a second time due to surgical problems.There was no blood loss except what was inside the replaced oxygenator.There was no patient injury or medical/surgical intervention required.Since the product was malfunctioned due to increased pressure, it was replaced.The final patient impact was no harm.
Additional Manufacturer Narrative
Implanted date: device was not implanted.Explanted date: device was not explanted.Occupation - perfusionist.Pma/510(k)- k130280.Review of the manufacturing record and the shipping inspection record of the actual product 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.(b)(4).
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to provide the device return date in section d9 and to update section h3.Visual inspection of the actual sample did not find any anomaly such as a breakage that could lead to the increasing of pressure.After rinsing and drying the actual sample, it was installed into a circuit consisting of tubes, and the pressure drop when circulating bovine blood (hct: 35%, temp.: 37°c) at a flow rate of 8l/min was measured.It was confirmed to meet the factory's specifications and no obstruction was found.After the investigation, saline solution was flowed in the blood channel.No blood clot that led to the increasing of pressure was formed.Review of the manufacturing record and the shipping inspection record 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, no anomaly was found in the actual sample after rinsing.As a possible cause of this complaint, since increased pressure was also confirmed in the competitor's oxygenator that was used before the replacement with the involved product, it was likely that blood-derived obstructing occurred for some reason.However, since there was no anomaly in the performance test of actual sample, it was not possible to clarify the cause of occurrence from the investigation result.Relevant ifu reference: "do not reduce heparin during circulation.Otherwise, blood clotting might occur.(warnings)"."adequate heparinization of the blood is required to prevent it from clotting in the system.(warnings)".

• Brand Name: CAPIOX FX25 OXYGENATOR
• Common Device Name: 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: 15050843
• Report Number: 9681834-2022-00142
• Device Sequence Number: 17283816
• Product Code: DTZ
• UDI-Device Identifier: 04987350701084
• UDI-Public: 04987350701084
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K071572
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/19/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2022
• Device Model Number: N/A
• Device Catalogue Number: CX*FX25W
• Device Lot Number: 190927
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/01/2022
• Supplement Date Received by Manufacturer: 08/15/2022
• Initial Report FDA Received Date: 07/19/2022
• Supplement Report FDA Received Date: 09/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/27/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 78 YR
• Patient Sex: Female
• Patient Weight: 44 KG