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  

Manufacturer Narrative

Implanted date: device was not implanted, explanted date: device was not explanted, establishment name: unknown, phone number: unknown, initial reporter name: unknown, occupation: cardiac surgeon, pma/510(k) no:k130520.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.The manufacturing record and the shipping inspection record of the actual product found no anomaly.No other similar report was found with the product of the involved product code/lot number.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).

Event Description

The user facility reported that the tube was not connected to the oxygenator as it should be connected.(connection, disconnecting) the event occurred pre-treatment.The procedure outcome was not reported.The final patient impact was not harmed.

Manufacturer Narrative

H6: investigation findings: code 3211 is based upon the video provided; code 3221 is based upon the device not returned.This report is being submitted as follow-up no.1 to provide the device return date in section d9, to update section h3, and to provide the completed investigation results.The actual device was difficult to obtain; therefore, an evaluation of the actual device was unable to be conducted.Confirmation of the provided video found that the tube was disconnected at the end of purge port on the oxygenator.It was not possible to confirm the state of adhesion to the purge port from the video.The manufacturing record and the shipping inspection record of the actual product found no anomaly.No other similar report of the product with the involved product code/lot number was found.Based on the investigation result, no anomaly was found in the manufacturing records of actual product.Since the state of adhesion to the purge port could not be confirmed from the provided video, it was not possible to identify the cause of occurrence.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.(method of operation, a.Set-up, 1, caution)".

Manufacturer Narrative

This report is being submitted as follow-up no.2 to provide the device return date in section d9, update section h3, and to provide the completed investigation results.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.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 (january 2021) to the date of occurrence (november 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.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.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.Relevent 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: 15932532
• MDR Text Key: 308186094
• Report Number: 9681834-2022-00247
• 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,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2022
• 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?: Yes
• Date Manufacturer Received: 06/15/2023
• 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