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

Model Number	N/A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/08/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E3: occupation: technologist.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.Review of the manufacturing record and the shipping inspection record of the actual sample confirmed that there was not any anomaly in them.A search of the past complaint file of the involved product code/lot number found one other similar complaint (240101600).For this previous case, no anomaly was found in the manufacturing related records, and it was judged not to be the problem of the product.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 that the sampling tube was broken.The event occurred pre-treatment.The procedure outcome was not reported.There was no harm to the patient.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to provide the device return date in section d9, update section h3, and to provide the completed investigation results.Visual inspection of the actual sample: it was confirmed that the sampling line tube connected to the venous blood port of reservoir was fractured at the connection between the port and the tube.Magnifying and electron microscopic inspections of the fractured part of actual sample.The fractured surface was found 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 adhesion surface was confirmed to be equivalent to that of a current product sample.A part of the sampling line of the actual sample was 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 differences were found in comparison with those of a current product.Simulation test: based on our experience, it is our knowledge that a similar fracture may occur when momentary external force is applied to the product while it is in a cooled state.Regarding the period from (b)(6) 2023 (from the serial number of the actual sample) to (b)(6) 2024 (the month of occurrence), the temperature at the involved area was investigated.It was found that the lowest 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.It was observed that a part of the tube may break at the connection with the product.Electron microscopic inspection of the fracture surface of the test sample found that its state was similar to that of the actual sample.The test conditions were set arbitrarily.Based on the investigation result, as a possible cause of occurrence, following factor was inferred from the condition of the fracture surface of actual sample and the simulation test result.However, it was not possible to clarify when the fracture occurred.It was likely that the product in question was subjected to some strong shock force during being handled when it was in a cooled state due to the distribution in the cold season or effect of storage environment, which resulted in 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 RX OXYGENATOR
• 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: 19182253
• Report Number: 9681834-2024-00069
• Device Sequence Number: 7109873
• 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): 04/25/2024

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/09/2024
• Supplement Date Received by Manufacturer: 04/24/2024
• Initial Report FDA Received Date: 04/25/2024
• Supplement Report FDA Received Date: 05/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/09/2024
• 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: 58 YR
• Patient Sex: Male