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

Model Number	CX*FX05RE
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/06/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that the blood inlet was deformed.The event occurred pre-treatment; therefore, there was no patient involved or harmed.The procedure outcome was not reported.
Additional Manufacturer Narrative
D6a: implanted date: device was not implanted.D6b: explanted date: device was not explanted.G4: pma/510(k): k130280.The actual sample underwent a visual inspection, and the following confirmations were made.The blue cap attached to the blood inlet port was torn.The distal end of the blood inlet port was deformed.The packaging bag of the actual sample was damaged, and a circular contact mark was observed.No abnormalities such as cracks or deformation were found in areas other than the blood inlet port.Simulation test using a factory-retained sample: an attempt was made to apply a shock force, similar to hitting a hard object, to the blood inlet port with the blue cap attached.As a result, a deformation similar to that observed on the actual sample occurred.Confirmation of the packaging condition: the packaging condition of the fx05rea product was checked, and it was confirmed that the circular mark on the packaging bag of the actual sample did not match the proper location where the blood inlet port would make contact.From this, it was inferred that the damage to the blood inlet port occurred after the actual sample was taken out of the box.The manufacturing record and the shipping inspection record of the actual sample found no anomaly.No other similar complaint was reported.Based on the investigation results, it was inferred that a strong shock force was applied to the blood inlet port of the actual sample over the blue cap, leading to the damage.Regarding the timing of the damage, it was observed that the damaged position on the packaging bag did not align with the proper contact position of the blood inlet port.This suggests that the damage occurred after the actual sample was removed from the box.However, it was not possible to determine the exact timing based on the condition of the actual sample.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." terumo medical products (tmp) (importer) registration no.2243441 is submitting this report on behalf of ashitaka factory of terumo corporation (manufacturer) registration no.9681834.

• 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: 20830970
• Report Number: 9681834-2024-00219
• Device Sequence Number: 21015131
• Product Code: DTZ
• UDI-Device Identifier: 04987350781758
• UDI-Public: (01)04987350781758(17)260228(10)230327
• 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): 12/03/2024

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 Expiration Date: 02/28/2026
• Device Model Number: CX*FX05RE
• Device Catalogue Number: N/A
• Device Lot Number: 230327
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/06/2024
• Initial Report FDA Received Date: 12/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/27/2023
• 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 Age: 24 MO
• Patient Sex: Female