MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA CAPIOX FX25 OXYGENATOR; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number	N/A
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/18/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The user facility reported there were issues with the involved capiox fx15 device during priming.There was a latency in the passage of priming the cardiotomy filter.Therefore, the user decided to replace the device.The final patient impact was not harmed.The event occurred pre-treatment.
Additional Manufacturer Narrative
Initial reporter occupation: perfusionist.Pma/510(k)- k130520.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.Review of the manufacturing record and the shipping inspection record of the actual product confirmed that there were not any indications of anomaly in them.A search of the complaint file found no other similar report with the involved product code/lot number combination.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).
Additional Manufacturer Narrative
Visual inspection of the actual sample did not find any anomaly such as a breakage.After rinsing and drying the actual sample, for the actual reservoir, the pressure drop when flowing in bovine blood (hct: 35%, temp.: 37°c) at a flow rate of 5l/min was measured.It was confirmed to meet the factory's specifications and no obstruction was found.The actual oxygenator was installed into a circuit consisting of tubes, and the pressure drop when circulating bovine blood (hct: 35%, temp.: 37°c) at a flow rate of 5l/min was measured.It was confirmed to meet the factory's specifications and no obstruction was found.Saline solution was flowed in the blood channel.No blood clot that led to the obstruction was formed.Review of the manufacturing record and the shipping inspection record of the actual sample 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 actual sample after rinsing.As a cause of occurrence, it was likely that blood-derived obstructing occurred for some reason.However, since there was no anomaly in the performance test of actual sample, it was not possible to clarify the cause of this complaint from the investigation result.
Event or Problem Description
Additional information was received on 19 sep 2022: it was confirmed that the oxygenator was not used for the cec; however, there was blood inside due to recirculating with the cannulated patient.When the issue was noticed, there was no time to stop the surgeon from aspirating blood from the operating field with the aspirator connected to the cardiotome.The blood was not infected and was heparinized.The device was replaced after the blood was circulating, including the aspirated blood, therefore this case was a serious injury.The event occurred intra-operative.There was no patient injury/medical or surgical intervention required.

• 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: 15129209
• Report Number: 9681834-2022-00157
• Device Sequence Number: 17504484
• Product Code: DTZ
• UDI-Device Identifier: 04987350701121
• UDI-Public: 04987350701121
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K071494
• 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): 07/29/2022

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: 03/31/2024
• Device Model Number: N/A
• Device Catalogue Number: CX*FX15RW40
• Device Lot Number: 210420
• 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: 07/18/2022
• Supplement Date Received by Manufacturer: 09/14/2022
• Initial Report FDA Received Date: 07/29/2022
• Supplement Report FDA Received Date: 10/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/20/2021
• 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