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

Model Number	CX*FX25RW
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/07/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that once opening the package, the connector of purge line to reservoir was found to be broken.The procedure outcome was not reported.The patient was not harmed.
Additional Manufacturer Narrative
E3: occupation: distributor.G4: pma/510(k): k130520.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 found no anomaly.No other similar issue has been reported.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).
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to provide the device return date in section d9 and to provide the completed investigation results.Visual inspection of the actual sample: it was confirmed that the l-shaped connector on the purge line had been fractured.The port of the reservoir to which the l-shaped connector was attached had been deformed.Upon magnifying inspection of the fracture surface of the l-shaped connector, a streaky pattern was observed extending from a specific point on some parts, while the remaining sections appeared smooth.From this, it was inferred that the fracture was caused by an application of momentary load.Simulation test: an attempt to apply momentary load to a factory-retained l-shaped connector from the top.As a result, the l-shaped connector was fractured, and the port of the reservoir was deformed.This condition was similar to that of the actual sample.Magnifying inspection of the fracture surface of the tested sample found a streaky pattern extending from a specific point on some parts, which was similar to that of the actual sample.Based on the investigation results of the actual sample including the mode of fracture and the result of the simulation test, it was thought that the cause of this incident was a momentary impact load applied to the l-shaped connector on the top of the reservoir.However, it was not possible to clarify when such an impact load was applied.Relevant instructions for use (ifu) reference: "do not use if the package or device is damaged (e.G.Cracked) or any of the port caps are off." "if the product is dropped during set-up, do not use it.Replace with another device.".

• 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: stephanie handy ; 265 davidson ave; suite 320; somerset, NJ 08873 ; 4103927218
• MDR Report Key: 20597448
• Report Number: 9681834-2024-00185
• Device Sequence Number: 6550797
• Product Code: DTZ
• UDI-Device Identifier: 04987350701046
• UDI-Public: (01)04987350701046(17)270430(10)240517
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• PMA/510(K) Number: K071494
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/04/2024

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*FX25RW
• Device Catalogue Number: CX*FX25RW
• Device Lot Number: 240517
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/07/2024
• Supplement Date Received by Manufacturer: 11/06/2024
• Initial Report FDA Received Date: 11/04/2024
• Supplement Report FDA Received Date: 11/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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