MAUDE Adverse Event Report: TERUMO MEDICAL CORPORATION CAPIOX FX15; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number	N/A
Medical Device Problem Code	Gas Output Problem (1266)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A1: patient identifier: requested, not provided.A2: age & date of birth: requested, not provided.A3: patient sex: requested, not provided.A4: weight: requested, not provided.A5: ethnicity: requested, not provided.A6: race: requested, not provided.B3: date of event: requested, unknown.D4: lot number: requested, unknown.D4: expiration date: unknown due to unknown lot number.D5: operator of device: unknown.D6a: implanted date: device was not implanted.D6b: explanted date: device was not explanted.E1: establishment address: requested, unknown.E1: initial reporter name : requested, unknown.E1: phone number: requested, unknown.E2: health professional: requested, not provided.E3: occupation: requested, not provided.G4: pma/510(k): unknown.H4: device manufacture date: unknown due to unknown lot number.The actual device was not returned; therefore, an evaluation of the actual device was unable to be conducted.The manufacturing record and the shipping inspection record of the actual product.Since the lot information was unknown, the manufacturing history records could not be investigated.The manufacturing date and the expiration date of the actual product.Since the lot information was unknown, the manufacturing history records could not be investigated.Past complaint file, no other similar report of the product with the involved product code was found for the past two years.Since detailed information was unknown, the cause of occurrence could not be clarified.The instructions for use (ifu) (capiox fx15) has the following warnings and precaution regarding gas transfer failure: start gas supply with v/q=1, and fio2=100%, then adjust based on blood gas measurements.Measure blood gases and make necessary adjustments as follows.A) control pao2 by changing concentration of oxygen in ventilating gas using gas blender.To decrease pao2, decrease fio2.To increase pao2, increase fio2.B) control paco2 by changing the total gas flow.To decrease paco2, increase total gas flow.To increase paco2, decrease total gas flow.Upon patient rewarming, adjust o2 concentration, gas flow rate and blood flow rate by increasing them as needed based on an increasing in patient's metabolism.Failure to adjust the gas supply and the blood flow rate appropriately may cause insufficient o2 supply needed or the amount of the patient's gaseous metabolism.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 involved device had a poor oxygenator performance.The problem occurred during a cardiopulmonary bypass.There was no delay in the beginning or continuing the surgical procedure.The product was not changed out.There was no blood loss because of the reported issue.The surgery was completed successfully.

• Brand Name: CAPIOX FX15
• Common Device Name: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): TERUMO MEDICAL CORPORATION; 950 elkton blvd.; elkton MD 21921
• 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: 17717143
• Report Number: 9681834-2023-00179
• Device Sequence Number: 12513683
• Product Code: DTZ
• UDI-Device Identifier: 04987350701206
• UDI-Public: 04987350701206
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/10/2023

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 Model Number: N/A
• Device Catalogue Number: CX*FX15W
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/11/2023
• Initial Report FDA Received Date: 09/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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