MAUDE Adverse Event Report: TERUMO MEDICAL CORPORATION CAPIOX RX15; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number	N/A
Medical Device Problem Codes	Break (1069); Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/10/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported leakage with the capiox device involved.The sampling line was broken at the connection with blood inlet.There was no patient injury/medical or surgical intervention required.The procedure outcome was not reported.The final patient impact was not harmed.The event occurred intra-operative.
Additional Manufacturer Narrative
A2: date of birth: requested, not provided a5: ethnicity: requested, not provided a6: race: requested, not provided d6a: implanted date: device was not implanted d6b: explanted date: device was not explanted e3: occupation: technologist the actual device has been returned for evaluation.The investigation is currently ongoing.A follow-up report will be submitted once the investigation is complete.Review of the manufacturing record and the shipping inspection record of the actual sample found no anomaly in them.A search of the past complaint file regarding the involved product code/lot number found no other similar report.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 correct sections d4, h4 and g4; update section h3, and to provide the completed investigation results.Visual inspection of the actual sample that the sampling line tube connected to the venous blood port of reservoir was fractured at the connection between the port and the tube.The support arm had been detached from the oxygenator.Magnifying and electron microscopic inspections of the fractured part of actual sample found the fracture surface to be smooth.From this, it was inferred that the fracture was caused by momentary force.In addition, no contamination by foreign matters or air leading to breakage was observed.The height of trace of solvent on the tube surface was confirmed to be equivalent to that of a current product sample.Magnifying inspection of the cross section of tube found a part of the sampling line of the actual sample cut, and the cross section of tube was subjected to magnifying inspection.No anomaly such as uneven wall thickness was found.The inner and outer diameters of the tube were measured, and no difference was found in comparison with those of a current product.Simulation test: by our experience, we are aware that a similar fracture may occur when momentary external force is applied while the product is in a cooled state.Regarding the period from the month of manufacture (september 2023 based on the serial number) to the month of occurrence (january 2024), the temperature at the involved area was investigated.It was found that the minimum temperature was below zero.Assuming that the fracture occurred during distribution or storage, a test sample was cooled and then exposed to momentary shock force.As a result, a part of the tube was fractured at the connection between the tube and the product.Electron microscopic inspection of the fracture surface of the test sample found that its condition was similar to that of the actual sample.(the test conditions were set arbitrarily.) review of the manufacturing record and the shipping inspection record of the actual sample found no anomaly in them.A search of the past complaint file regarding the involved product code/lot number found no other similar report.Based on the investigation result, as a possible cause of occurrence, following factor was inferred from the condition of the fractured surface of the actual sample and the simulation test result.However, it was not possible to clarify when the fracture occurred.The actual sample, which was in a cooled state due to the distribution in the cold season or effect of storage environment, was subjected to some strong shock force during being handled, leading to the fracture.Relevant instructions for use (ifu) reference: "if the product is dropped during set-up, do not use it.Replace with another device.".

• Brand Name: CAPIOX RX15
• Common Device Name: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): TERUMO MEDICAL CORPORATION; 950 elkton blvd.; elkton MD 21921
• 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: 18614081
• Report Number: 9681834-2024-00008
• Device Sequence Number: 7416909
• Product Code: DTZ
• UDI-Device Identifier: 04987350769572
• UDI-Public: 04987350769572
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K040210
• 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): 01/31/2024

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: 08/31/2026
• Device Model Number: N/A
• Device Catalogue Number: CX*RX25RW
• Device Lot Number: 230901
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/10/2024
• Supplement Date Received by Manufacturer: 02/08/2024
• Initial Report FDA Received Date: 01/31/2024
• Supplement Report FDA Received Date: 02/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2023
• 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: 65 YR
• Patient Sex: Male
• Patient Weight: 55 KG