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

Model Number	N/A
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/22/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that during cardiopulmonary bypass, an air leak occurred.The surgery was completed successfully without exchanging the involved product.The event resulted in delay in the beginning or continuing the procedure.The reported event did not cause or contribute to an injury, and no blood loss was reported.
Additional Manufacturer Narrative
A1: patient identifier: requested, not provided a2: age & date of birth: requested, not provided a3a: sex: requested, not provided a3b: gender: requested, not provided a4: weight: requested, not provided a5: ethnicity: requested, not provided a6: race: requested, not provided d6a: implanted date: device was not implanted d6b: explanted date: device was not explanted e2: health professional: unknown e3: occupation: chief perfusionist.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.The manufacturing record and the shipping inspection record of the actual product found no anomaly.No other similar report of the product with the involved product code/lot number was found.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 the device return date in section d9, update section h3, and to provide the completed investigation results.Visual inspection of the actual sample upon receipt found no anomaly such as a breakage.After rinsing the actual sample, it was installed into a circuit consisting of tubes, and the saline solution was circulated through the actual sample.No leakage or residual air was found.Bovine blood (temp.: 37°c, hb: 12g/dl) was circulated through the actual sample at a blood flow rate of 1.5 l/min.No leakage or air mixing was found.The bubble removal performance of actual sample was confirmed.10ml of air was flowed from the blood inlet port side of oxygenator while bovine blood was circulating under the following conditions.No air to flow out of the oxygenator through the filter was found.An arterial filter was connected to the blood outlet port side, and it was confirmed whether air flowed into the oxygenator and arterial filter.[bovine blood conditions] hb: 12g/dl, temp.: 37°c.[circulation conditions] blood flow rate: 0.5l/min, 1.0l/min and 1.5l/min, back pressure: 200mmhg.The manufacturing record and the shipping inspection record of the actual sample found no anomaly.No other similar report was found.Based on the investigation result, no anomaly that could lead to leakage or air mixing was found in the actual sample.In addition, no anomaly was found in the bubble removal performance test result of the actual sample.As a possible cause of occurrence, it was likely that due to some factor, air was flowed into the oxygenator or air remained following priming.However, since no anomaly was found in the actual sample, it was not possible to clarify the cause of this case.For future reference, instructions for use (ifu) (capiox fx05) has the following caution and warnings regarding air mixing: "ensure that the de-airing process is complete prior to initiating bypass.(c.Initiation of bypass)." "during recirculation, do not use pulsatile flow and do not stop the blood pump suddenly as these actions may cause gaseous emboli to enter the blood phase from the gas phase due to inertia force.(warnings)" "do not obstruct gas outlet port.Avoid build up of excess pressure in the gas phase to prevent gaseous emboli entering the blood phase.(warnings)." "pressure in the blood phase should always be higher than that in the gas phase to prevent gaseous emboli entering the blood phase.(warnings)." "the gas flow rate should not exceed 5l/min.Excessive gas flow rate will bring about pressure increase in the gas phase, allowing gaseous emboli to enter the blood phase.(warnings).".

• Brand Name: CAPIOX FX OXYGENATOR
• 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 ; 4103927218
• MDR Report Key: 19547404
• Report Number: 9681834-2024-00106
• Device Sequence Number: 15154961
• Product Code: DTZ
• UDI-Device Identifier: 04987350739087
• UDI-Public: 04987350739087
• 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
• Report Date (Section B): 06/17/2024

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: 08/31/2026
• Device Model Number: N/A
• Device Catalogue Number: 1CX*FX05RWA
• Device Lot Number: 230920
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/22/2024
• Supplement Date Received by Manufacturer: 06/19/2024
• Initial Report FDA Received Date: 06/17/2024
• Supplement Report FDA Received Date: 07/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/20/2023
• 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