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

Model Number	N/A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/05/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that the capiox oxygenator was damaged b.U.Temperature probes on fx05 were broken.The procedure outcome was not reported.The patient was not harmed.
Additional Manufacturer Narrative
E3: occupation: perfusionist.G4: pma/510(k) - k130520.Review of the manufacturing record and the shipping inspection record of the actual product confirmed that there was not any anomaly in them.A search of the complaint file found no other similar report of the product with the involved product code/lot# from the same facility and other facilities.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.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 a correction in section b3 as the date of event inadvertantly had the incorrect year and to provide the completed investigation results.1.Investigation of the actual sample: 1.1 visual inspection of the actual sample · it was found that the thermistor probe on the venous blood inlet port had been damaged from the root.1.2 magnifying and electron microscopic inspection of the fracture surface of actual sample · no anomaly such as mixing of foreign substance or air that could lead to fracture was found.· the fracture surface had both smooth surface and rough surface.Since smooth part was found on the fracture surface of actual sample, it was inferred that it was damaged due to momentary force applied on it.2.Simulation test: · from the status of the fracture surface of actual sample, assuming that momentary force was applied and the product was damaged, momentary force was applied to the thermistor probe on the factory-retained product.As a result, damage form similar to the actual sample was simulated.3.Record review: 3.1 the manufacturing history record and the shipping inspection record of the actual sample · no anomaly was found.3.2 past complaint file · no other similar report of the product with the involved product code/lot number was found.3.3 manufacturing date: march 8, 2022.4.Cause of occurrence/conclusion: based on the investigation result, as a possible cause of this case, it was inferred that some momentary force exceeding the limit strength was applied to the thermistor probe on the venous blood inlet port, leading to damage.However, it was not possible to specify when the actual sample was damaged from its status, and the cause of occurrence could not be clarified.Relevant ifu reference: "if the product is dropped during set-up, do not use it.Replace with another device.(a.Set-up, caution)".Terumo medical products (tmp) (importer) registration no.(b)(4) is submitting this report on behalf of ashitaka factory of terumo corporation (manufacturer) registration no.(b)(4).

• 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: gina digioia ; 265 davidson ave; suite 320; somerset, NJ 08873 ; 6402040886
• MDR Report Key: 17263983
• Report Number: 9681834-2023-00135
• Device Sequence Number: 7912324
• Product Code: DTZ
• UDI-Device Identifier: 04987350781758
• UDI-Public: 04987350781758
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 07/06/2023

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: 02/28/2025
• Device Model Number: N/A
• Device Catalogue Number: CX*FX05RE
• Device Lot Number: 220308
• 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: 06/06/2023
• Supplement Date Received by Manufacturer: 06/28/2023
• Initial Report FDA Received Date: 07/06/2023
• Supplement Report FDA Received Date: 07/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/08/2022
• 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