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

Model Number	CX*RX05RW
Medical Device Problem Code	Air/Gas in Device (4062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/13/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A1: patient identifier: requested, not provided.A2: date of birth: requested, not provided.A3b: gender: 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.E1: initial reporter name: requested, unknown.E1: phone number: requested, unknown.G4: pma/510(k): k130493.The actual sample was not returned.Confirmation of the provided image: it was found that air was mixed into the top surface of oxygenator.From the image, it was inferred that it was time to replace the priming fluid with blood.The manufacturing record and the shipping inspection record of the actual sample found no anomaly.No other similar report of the product with the involved product code/lot number was found.Based on the investigation result, no anomaly was found in the manufacturing records.Based on the provided image, it was likely that air was mixed when replacing the priming fluid with blood.Due to this, it was inferred that air was flowed into the oxygenator for some factor, or that air remained in the oxygenator during priming.However, since the actual sample could not be confirmed, it was not possible to clarify the cause of occurrence.Relevant instructions for use (ifu) reference: "ensure that the de-airing process is complete prior to initiating 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." "do not obstruct gas outlet port.Avoid buildup of excess pressure in the gas phase to prevent gaseous emboli entering the blood phase." "pressure in the blood phase should always be higher than that in the gas phase to prevent gaseous emboli entering the blood phase." "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." "to prevent gaseous emboli from entering the blood phase, make sure that the arterial pump flow rate always exceeds the flow rate of the cardioplegia line.The blood flow rate of the cardioplegia line should not exceed 0.5l/min." "recirculate the priming solution at a rate of 0.5 l/min or higher to facilitate air removal." 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 as soon as cpb start, the air bubbles were found and could not be removed.A new device was placed to complete the procedure.There was no health hazard to the patient.The procedure outcome was not reported.The patient was not harmed.

• Brand Name: CAPIOX®RX
• 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 ; 265 davidson ave; suite 320; somerset, NJ 08873 ; 9499890491
• MDR Report Key: 20878123
• Report Number: 9681834-2024-00224
• Device Sequence Number: 7683628
• Product Code: DTZ
• UDI-Device Identifier: 04987350763471
• UDI-Public: (01)04987350763471(17)270228(10)240311
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K022115
• 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): 12/09/2024

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 Model Number: CX*RX05RW
• Device Catalogue Number: N/A
• Device Lot Number: 240311
• 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: 11/14/2024
• Initial Report FDA Received Date: 12/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/11/2024
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 3 YR
• Patient Sex: Male
• Patient Weight: 16 KG