MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA CAPIOX FX05; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number	CX*FX05RWA
Medical Device Problem Codes	Use of Device Problem (1670); Obstruction of Flow (2423)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Serious Injury
Event or Problem Description
The user facility reported that there was a membrane oxygenator clot causing system high pressure and failure to initiate cardiopulmonary bypass.The event reached the patient causing significant harm or required major intervention.The patient had venous line open and found to have obstruction to forward flow.Oxygenator was changed out prior to canceling procedure.It was unknown if the procedure was completed successfully.
Additional Manufacturer Narrative
B3: date of event: requested, not provided.D6a: implanted date: device was not implanted.D6b: explanted date: device was not explanted.E1: telephone number: requested, unknown.E2: health professional: unknown.E3: occupation: administrator/ supervisor.G4: pma/510(k): k130280.The actual device has not been returned for evaluation.The investigation is currently ongoing.A follow-up report will be submitted once the investigation is complete.There was no anomaly found in the manufacturing record and the shipping inspection record of the actual product.No other similar report of the product with the involved product code/lot number was found.Terumo medical products (tmp) (importer) registration no.2243441 is submitting this report on behalf of ashitaka factory of terumo corporation (manufacturer) registration no.9681834.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to provide additional information to section b5 and h6, provide a correction to sections d4 and h4, and provide the completed investigation results.The manufacturing record and the shipping inspection record of the actual product found no anomaly.No other similar report of the product with the involved product code/lot number was found.Based on the investigation result, from the additional information obtained, it was inferred that the actual product was obstructed due to the formation of blood clots.However, since the actual sample could not be investigated, it was not possible to clarify the cause of occurrence.In order to clarify the cause of occurrence, we would like to ask for your cooperation in obtaining the actual sample.The instructions for use (ifu) (capiox fx05) has the following warnings regarding blood clot formation."do not reduce heparin during circulation.Otherwise, blood clotting might occur." "adequate heparinization of the blood is required to prevent it from clotting in the system.".
Event or Problem Description
Additional information was received on (b)(6) 2025: the event was recognized by the hospital as human error, not a device malfunction.It was stated that the associate set the pressure limits at 575.It was believed that he overrode the safety limits, along with other errors; therefore, he was let go.

• Brand Name: CAPIOX FX05
• 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 ; 265 davidson ave; suite 320; somerset, NJ 08873 ; 9499890491
• MDR Report Key: 20989514
• Report Number: 9681834-2024-00245
• Device Sequence Number: 7778953
• Product Code: DTZ
• UDI-Device Identifier: 04987350739087
• UDI-Public: (01)04987350739087(17)260430(10)230529
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/20/2024

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: 04/30/2026
• Device Model Number: CX*FX05RWA
• Device Catalogue Number: CX*FX05RWA
• Device Lot Number: 230529
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/10/2024
• Supplement Date Received by Manufacturer: 01/20/2024
• Initial Report FDA Received Date: 12/20/2024
• Supplement Report FDA Received Date: 01/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/29/2023
• 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: Required Intervention
• Patient Sex: Unknown