MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA CAPIOX FX25 OXYGENATOR; 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	07/12/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient identifier: no patient involvement.Age & date of birth: no patient involvement.Patient sex: no patient involvement.Weight: no patient involvement.Ethnicity: no patient involvement.Race: no patient involvement.Implanted date: device was not implanted.Explanted date: device was not explanted.Occupation - chief perfusionist.The actual device was not returned; therefore, an evaluation of the actual device was unable to be conducted.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 with the involved product code/lot number combination.Based on the investigation result, no anomaly was found in the manufacturing record.As a possible cause of this complaint, it was inferred that during distribution and storage, the actual product was damaged due to sudden shock force applied on it.However, since the actual product was not returned and it could not be confirmed, the cause of occurrence could not be clarified.In the ashitaka factory, this event was provided to the manufacturing process, and instructed workers to continue to implement 100% visual inspection which has been performed during the manufacturing process.The workers were also instructed to pay attention to the handling of the product.The instructions for use (ifu) (capiox fx25) of ashitaka factory has the following caution: "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).
Event or Problem Description
The user facility reported that the oxygenator device involved had a broken oxygenator port.The event occurred when out of the box during pre-set up.The product was not used and was not exchanged out.The event did not delay the beginning or continuing of the surgical procedure.The product malfunction did not cause or contribute to an injury.

• 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: 15128178
• Report Number: 9681834-2022-00156
• Device Sequence Number: 17798505
• Product Code: DTZ
• UDI-Device Identifier: 04987350701060
• UDI-Public: 04987350701060
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/29/2022

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: 06/30/2023
• Device Model Number: N/A
• Device Catalogue Number: 1CX*FX25E
• Device Lot Number: 200710
• 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: 07/12/2022
• Initial Report FDA Received Date: 07/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/10/2020
• 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