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

Model Number	CX*FX05RWA
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/16/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D6a: implanted date: device was not implanted.D6b: explanted date: device was not explanted.E2: health professional: unknown.E3: occupation: director of cardiovascular perfusion.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.It was initially reported that the involved product code was cx*fx05rw and the lot number was 230529.However, upon investigation, it was determined that no product with this specific combination exists.Therefore, the investigation was conducted with an unknown lot number at this stage.Since the involved lot number was unknown, it could not be confirmed.There have been no reports of tubing disconnection related to the involved product code in the past two years.Terumo medical products (tmp) (importer) registration no.2243441 is submitting this report on behalf of ashitaka factory of terumo corporation (manufacturer) registration no.9681834.
Event or Problem Description
The user facility reported that the sucker prime tubing was disconnected.The event occurred during pre-cardiopulmonary bypass.The event did not result in a delay in the beginning or continuing the surgical procedure.The exact tubing was livanova.The product was not changed out and the surgery was completed successfully.The product malfunction did not cause or contribute to an injury.No blood loss was reported.
Additional Manufacturer Narrative
Manufacturing record and the shipping inspection record of the actual sample found no anomaly.No complaints were received regarding "sucker prime tubing disconnected" in the past.
Additional Manufacturer Narrative
This report is being submitted as follow up no.2 to provide the completed investigation results.No actual sample was returned.Based on the investigation result, no anomaly was found in the manufacturing record and the shipping inspection record.Since it was not possible to confirm the actual sample in this case, it was not possible to clarify the cause.Please note that the instructions for use (ifu) of capiox fx05 indicates the following for your reference: "band all connections in the circuit." "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.".

• Brand Name: CAPIOX FX 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: gina digioia ; 265 davidson ave; suite 320; somerset, NJ 08873 ; 4103927218
• MDR Report Key: 19741730
• Report Number: 9681834-2024-00119
• Device Sequence Number: 7655399
• Product Code: DTZ
• UDI-Device Identifier: 04987350739087
• UDI-Public: (01)04987350739087(17)260430(10)230529
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,Followup
• Report Date (Section B): 07/15/2024

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 Expiration Date: 04/30/2026
• Device Model Number: CX*FX05RWA
• Device Catalogue Number: CX*FX05RWA
• Device Lot Number: 230529
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/16/2024
• Supplement Date Received by Manufacturer: 07/16/2024; 08/09/2024
• Initial Report FDA Received Date: 07/15/2024
• Supplement Report FDA Received Date: 08/09/2024; 08/30/2024
• 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
• Patient Sex: Unknown