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

Model Number	CX*FX05RW
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/23/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that the blood inlet port was deformed/kinked.The procedure outcome was not reported.The event occurred pre-treatment and there was no patient involvement.
Additional Manufacturer Narrative
G4: pma/510(k): k130280 the actual sample was discarded by the involved facility.The provided image of the actual sample showed that the blood inlet port of the oxygenator was deformed.Manufacturing record and the shipping inspection record of the actual sample found no anomaly.No other similar report was found.According to the investigation result, no anomaly was found in the manufacturing records.Based on the provided image, it was inferred that some kind of external force was applied to the blood inlet port, leading to the deformation.However, since it was not possible to confirm the actual sample, the cause could not be clarified.Relevant instructions or use (ifu) reference: "if the product is dropped during set-up, do not use it.Replace with another device." terumo medical products (tmp) (importer) registration no.(b)(4) is submitting this report on behalf of ashitaka factory of terumo corporation (manufacturer) registration no.9681834.

• 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: 20452768
• Report Number: 9681834-2024-00178
• Device Sequence Number: 12892811
• Product Code: DTZ
• UDI-Device Identifier: 04987350781772
• UDI-Public: (01)04987350781772(17)270131(10)240202
• 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): 10/15/2024

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: 240202
• 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: 09/23/2024
• Initial Report FDA Received Date: 10/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/02/2024
• 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
• Patient Age: 3 YR
• Patient Sex: Male