MAUDE Adverse Event Report: TERUMO MEDICAL CORPORATION CAPIOX FX OXYGENATOR; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number	N/A
Medical Device Problem Code	Backflow (1064)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/24/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that during the perfusion procedure with the entire system supplied (reservoir, oxygenator, tubing pack set) during surgery.Initially fully functional, after clamping the aorta plus cardioplegia, it became apparent that no corresponding backflow/cardiac relief was achieved.Despite the support of suction, the situation could not be improved.The error was determined to be that the rubber stopper on one of the 6 standard suction adapters on the reservoir came loose/was lost - for no identifiable reason.By closing the port, suction could be rebuilt, and efficient drainage was established.The event occurred intra-operative.No patient involvement.The procedure outcome was completed successfully.The final patient impact was not harmed.
Additional Manufacturer Narrative
D6a: implanted date: device was not implanted; d6b: explanted date: device was not explanted; e3: occupation: perfusionist.The actual device was not returned; therefore, an evaluation of the actual device was unable to be conducted.The manufacturing record and the shipping inspection record of the actual product, since the lot information was unknown, the investigation could not be carried out.Information for the past two years for the involved product code, no complaint regarding the failure in suctioning blood and the detachment of caps were reported.Since the lot information was unknown, the manufacturing date could not be confirmed, the di no.Only is reported since the involved lot number was unknown.As for the cause of this incident, the following possibilities were inferred since the description of the event indicated that the problem was solved by closing the venous blood port on top of the reservoir; however, the cause could not be determined because we were unable to confirm whether or not the reservoir had anomalies.The loose cap and other problems caused uncontrolled pressure in the reservoir, resulting in the failure in suctioning blood.Due to the failure in suctioning blood, the blood volume in the reservoir and blood flow rate could not be maintained, and the flow rate of the cardioplegia line could not be held.Relevant instructions for use (ifu) reference: do not use if the package or device is damaged (e.G., cracked) or any of the port caps are off.Ensure that all connected parts including the luer caps, the lock adapters and the port caps are securely affixed.Loose connections may cause contamination or a blood leak.Terumo medical products (tmp) (importer) registration no.2243441 is submitting this report on behalf of ashitaka factory of terumo corporation (manufacturer) registration no.9681834.

• Brand Name: CAPIOX FX OXYGENATOR
• Common Device Name: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): TERUMO MEDICAL CORPORATION; 950 elkton blvd.; elkton MD 21921
• Manufacturer (Section G): TERUMO CORPORATION, ASHITAKA; reg. no. 9681834; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• Manufacturer Contact: gina digioia ; 265 davidson ave; suite 320; somerset, NJ 08873 ; 4103927218
• MDR Report Key: 18823410
• Report Number: 9681834-2024-00027
• Device Sequence Number: 7216132
• Product Code: DTZ
• UDI-Device Identifier: 04987350701022
• UDI-Public: 04987350701022
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K071494
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: CX*FX25RE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/02/2024
• Initial Report FDA Received Date: 03/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Patient Sex: Male
• Patient Weight: 98 KG