MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA CAPIOX FX25 OXYGENATOR; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number N/A

Device Problem Connection Problem (2900)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/06/2022

Event Type  malfunction  

Event Description

The user facility reported that the tube was not connected to the oxygenator as it should be connected.(connection, disconnecting).The procedure outcome was not reported and the patient was not harmed.

Manufacturer Narrative

Patient identifier: requested, not provided.Age & date of birth: requested, not provided.Patient sex: requested, not provided.Weight: requested, not provided.Ethnicity: requested, not provided.Race: requested, not provided.Implanted date: device was not implanted.Explanted date: device was not explanted.Health professional: unknown.Occupation: others.Pma/510(k) no: k130520.The actual sample was discarded by the involved facility; therefore, the actual device will not be returned for evaluation.Record review: confirmation result of the provided video.The tube was not connected to the purge port of oxygenator.It was not possible to confirm the connection status to the purge port (tube was disconnected, tube was fractured, or adhesion failure) from the video.The manufacturing record and the shipping inspection record of the actual product; no anomaly was found.Past complaint files: no other similar report was found with the product of the involved product code/lot#.Based on the investigation result, no anomaly was found in the manufacturing records of actual product.Since the connection status to the purge port could not be confirmed from the provided video, the cause of occurrence could not be identified.Ifu states: "do not use if the package or device is damaged (e.G.Cracked) or any of the port caps are off.(method of operation, a.Set-up, 1, caution)" terumo medical products (tmp) (importer) registration no.2243441 is submitting this report on behalf of ashitaka factory of terumo corporation (manufacturer) registration no.(b)(4).

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.1: investigation of the actual sample: 1.1.Visual inspection of the actual sample · it was found that the purge line connected to the oxygenator had been fractured at the connection with the oxygenator port.1.2.Magnifying and electron microscopic inspections of the fractured section of purge line of the actual sample · it was found that the fracture surface was smooth and there were streak patterns on it.Therefore, it was inferred that fracture occurred due to momentary force applied on it.No anomaly such as mixing of foreign substance or air that could lead to cutting was found.1.3.A part of purge line of the actual sample was cut, and magnifying inspection of the cross section of tube was performed · no anomaly such as uneven thickness was found.· inner and outer diameters of the tube were measured.No difference was found when compared with the current product.2: simulation test: we have experienced that similar fracture may have been occurred when momentary external force was applied while the product was cold.The local temperature from the serial number of actual sample (on b)(6) 2021) to the date of occurrence ( on (b)(6 2022) was investigated.It was found that the minimum temperature was below 0°c.Assuming that an event occurred while the product was being stored during distribution, after cooling the sample in the unit box, it was dropped from a height of 1.5m.As a result, it was found that a part of the tube fractured at the connection with the product.·electron microscopic inspection of the fracture surface of sample found that it was similar to that of the actual sample.The test conditions were set arbitrarily.3: record review: 3.1.The manufacturing record and the shipping inspection record of the actual sample no anomaly was found.3.2.Past complaint file · one similar report ((b)(4)) of the product with the involved product code/lot# was found.3.3.Manufacturing date: january 29, 2021 4: cause of occurrence/conclusion: 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.When the involved product was handled in a cooled state due to the temperature during the distribution process in the cold season and the storage environment, some strong impact load was applied, leading to fracture.Relevant ifu reference: "if the product is dropped during set-up, do not use it.Replace with another device.(a.Set-up, caution)" 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 FX25 OXYGENATOR
• Type of Device: 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: gina digioia ; reg. no. 2243441; 950 elkton blvd.; elkton, MD 21921 ; 6402040886
• MDR Report Key: 15933127
• MDR Text Key: 308482533
• Report Number: 9681834-2022-00249
• Device Sequence Number: 1
• Product Code: DTZ
• UDI-Device Identifier: 04987350701046
• UDI-Public: 04987350701046
• Combination Product (y/n): N
• Reporter Country Code: KZ
• PMA/PMN Number: K071494
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/07/2022

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 Operator: Health Professional
• Device Expiration Date: 12/31/2023
• Device Model Number: N/A
• Device Catalogue Number: CX*FX25RW
• Device Lot Number: 210129
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/09/2022
• Initial Date FDA Received: 12/07/2022
• Supplement Dates Manufacturer Received: 06/15/2023
• Supplement Dates FDA Received: 07/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/29/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1