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

Model Number	CX*FX05RW
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/24/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
G4: pma/510(k): k130280.Visual inspection of the actual sample found that the blood inlet port had to have been fractured at the base.No cracks, deformations, or other anomalies were observed around the blood inlet port.Magnifying inspection of the actual sample found that the fracture surface was smooth overall, and a rippled pattern was observed on the bottom-of-oxygenator side with a striated pattern extending from there.Any foreign matter mixed in the material, which could lead to a decrease in strength, was not observed.From this, it was inferred that the blood inlet port of the actual sample was subjected to an instantaneous load from the bottom side of the oxygenator, and the fracture extended in the direction of the stripe pattern, starting from the center of the ripple pattern.The manufacturing record and the shipping inspection record of the actual sample found no anomaly.Past complaint file of the involved product code/lot number found no other similar report.Based on the results of the investigation, as cause of the reported event, it was likely that some kind of strong impact load was applied around the blood inlet port from the bottom side of the oxygenator, which resulted in the fracture.Regarding the timing at which such a strong impact load was applied, since no anomalies were observed in the manufacturing records, it was conceivable that an impact load was unexpectedly applied during distribution or storage; however, exact timing could not be determined from 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.
Event or Problem Description
The user facility reported blood inlet port breakage.The event occurred pre-treatment.The procedure outcome was not reported.The final patient impact was not harmed.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to provide a correction to sections d1: brand name, d4: model number, d4: catalog number, and d4: udi.The udi was updated to match the correct format.Due to internal review, a correction was made to section d3.

• Brand Name: CAPIOX®FX
• Common Device Name: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomya city, MD 418 ; JA 418
• Manufacturer (Section G): TERUMO CORPORATION, ASHITAKA; reg. no. 9681834; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• Manufacturer Contact: gina digioia ; 265 davidson ave; suite 320; somerset, NJ 08873 ; 4103927218
• MDR Report Key: 18208270
• Report Number: 9681834-2023-00226
• Device Sequence Number: 15296960
• Product Code: DTZ
• UDI-Device Identifier: 04987350781772
• UDI-Public: (01)04987350781772(17)260131(10)230209
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/27/2023

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
• Device Expiration Date: 01/31/2026
• Device Model Number: CX*FX05RW
• Device Catalogue Number: N/A
• Device Lot Number: 230209
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/28/2023
• Supplement Date Received by Manufacturer: 08/08/2024
• Initial Report FDA Received Date: 11/27/2023
• Supplement Report FDA Received Date: 08/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/09/2023
• 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: 3 YR
• Patient Sex: Male