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

Model Number	CX*FX05RW
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/17/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported leakage, the priming solution could not be pumped into the oxygenator and fill the chamber, which were filled with amounts of bubbles.Then a new device was replaced to complete the operation.The procedure was completed successfully.The patient was not harmed.
Additional Manufacturer Narrative
A1: patient identifier: requested, not provided.A2: date of birth: requested, not provided.A3b: gender: requested, not provided.A4: weight: 5.5kgs.A5: ethnicity: requested, not provided.A6: race: requested, not provided.D6a: implanted date: device was not implanted.D6b: explanted date: device was not explanted.E1: contact: requested, unknown.E1: telephone number: requested, unknown.G4: pma/510(k): k130280.The provided images of the actual sample revealed the following: the oxygenator was not filled with blood, and air was mixed in.The oxygenator was tinted red up to the upper part of the filter, indicating that the actual sample was previously filled completely with blood.There was no blood flowing through the purge line.Visual inspection of the actual sample did not identify any anomalies such as breakage that could result in air ingress.The actual sample underwent cleaning and was subjected to the air bubble removal performance test.It was installed into a circuit consisting of tubing and filled with saline solution.The saline solution was then replaced with bovine blood.During circulation with a flow rate of 1.5l/min, the priming process was successfully completed without any air mixing in.Subsequently, while circulating bovine blood under the following conditions, 10 ml of air was introduced into the actual sample from the blood inlet port side.It was observed that no air flowed out from the oxygenator through the filter.(*note: an arterial filter is connected to the blood outlet port side to check if air flowing out to the oxygenator and the arterial filter.) [blood conditions] hb: 12 g/dl, temperature: 37°c [circulation conditions] blood flow rate: 0.5 l/min, 1.0 l/min, and 1.5 l/min.Back pressure: 200 mmhg.Simulation test based on the provided image of the actual sample during use, where no blood flow was observed through the purge line, it was thought that the purge line was closed.The ifu of this product states in the priming procedure section, "remove the air while opening the purge line." to assess the ease of air removal depending on whether the purge line is open or closed, the following simulation test was conducted.Air was intentionally injected into the oxygenator after priming was completed, and then bovine blood was circulated at a flow rate of 1.5 l/min.It was confirmed that air escaped from the purge line when the purge line was open.Conversely, when the purge line was closed, no air escaped, thus replicating the situation observed during the event.The manufacturing record and the shipping inspection record of the actual sample no anomaly was found in them.Past complaint file of the involved product code/lot no similar complaint was received.Manufacturing date: december 4, 2023 expiration date: november 30, 2026 cause of occurrence/conclusion based on the investigation results, no anomalies that would result in air mixing into the actual sample were observed.Based on the provided images, it was inferred that discharging air was difficult because the purge line was closed.As no issues were identified in the actual sample, the exact cause could not be determined conclusively.Relevant ifu reference: "after priming, if air bubbles continue to appear, identify the cause and make necessary corrections.Remove the air while opening the purge line." 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 FX 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: gina digioia ; 265 davidson ave; suite 320; somerset, NJ 08873 ; 4103927218
• MDR Report Key: 20189693
• Report Number: 9681834-2024-00159
• Device Sequence Number: 18160056
• Product Code: DTZ
• UDI-Device Identifier: 04987350781772
• UDI-Public: (01)04987350781772(17)261130(10)231204
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K071572
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/11/2024

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 Model Number: CX*FX05RW
• Device Catalogue Number: CX*FX05RW
• Device Lot Number: 231204
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/17/2024
• Initial Report FDA Received Date: 09/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/04/2023
• 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 Age: 1 MO
• Patient Sex: Female