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

Model Number	CX*FX05RW
Medical Device Problem Code	Lack of Effect (4065)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/11/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A1: patient information: requested, not provided.D6a: implanted date: device was not implanted.D6b: explanted date: device was not explanted.E3: occupation: head of cardiac technology.G4: pma/510(k): k130280.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.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 and lot number no other similar issue has been reported.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 reported that air bubbles keep forming on the fx05, indicating a problem with the membrane.The membrane should be checked for leaks because air can penetrate the oxygenator.The procedure outcome was not reported.There was no patient involved.
Additional Manufacturer Narrative
This report is being sent as follow-up no.1 to update section d9, section h3, and to provide the completed investigation results.The actual device has been returned for evaluation.Investigation of the actual sample visual inspection of the actual sample - no anomaly such as damage that could lead to air mixing was found.The bubble removal performance of actual sample (after rinsing) was confirmed.- the actual sample was inserted into a circuit consisting of tubes, and after filling with saline solution, it was replaced with bovine blood and circulated at a flow rate of 1.5 l/min.As a result, it was confirmed that priming was completed without air being mixed in.- 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 record review the manufacturing record and the shipping inspection record of the actual sample.- no anomaly was found.Past complaint file - no other similar report of the product with the involved product code/lot number was found.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 corporation (tmc) (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
• 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: 21098851
• Report Number: 9681834-2024-00246
• Device Sequence Number: 18428278
• Product Code: DTZ
• UDI-Device Identifier: 04987350781772
• UDI-Public: (01)04987350781772(17)261031(10)231127
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/07/2025

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: 231127
• 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: 12/11/2024
• Supplement Date Received by Manufacturer: 01/27/2025
• Initial Report FDA Received Date: 01/07/2025
• Supplement Report FDA Received Date: 02/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/27/2023
• 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