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

Catalog Number CX*FX25RE

Device Problem Material Separation (1562)

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

Event Date 10/30/2021

Event Type  malfunction  

Manufacturer Narrative

Implanted date: device was not implanted.Explanted date: device was not explanted.The actual sample was received for evaluation.Visual inspection revealed that the lock adapter had been come off from the male connector of sampling system.The lock adapter that was come off was not returned.Magnifying inspection of the actual sample did not find any anomaly including a deformation on the male connector.The outer diameter of the rib of actual male connector was measured and was compared with its factory-retained product.No difference was found.The surface of actual male connector was elementally analyzed by sem-edx (scanning electron microscope / energy dispersive x-ray spectroscopy).As a result, si was detected, which was likely to be derived from the silicone applied to the cock of the three-way stopcock for the purpose of improving lubricity.Simulation test: as a simulation test, after applying silicone to the male connector of a factory-retained sampling system, the female connector was connected, and applied torque force to the lock adapter.As a result, it was found that the lock adapter was come off.Product structure: the sampling system is designed so that the internal step of lock adapter is caught on the rib of male connector so that it will not loosen when fitted with the female lure.Therefore, if the rib is completely overcome for some reason, the fitting may come off.A review of the device history record and the product release decision control sheet of the involved product code/lot# combination was conducted with no findings.Ifu states: do not use if the package or device is damaged (e.G.Cracked) or any of the port caps are off.Based on the provided information and investigation results, there is no definitive evidence that this event was related to a device defect or malfunction.It was likely that since the silicone applied to the cock of sampling system for the purpose of improving lubricity was transferred to the male connector for some reason, it came off when the lock adapter was tightened.However, from the state of the actual sample, it was not possible to clarify when the silicone was transferred to the male connector.The exact cause of the reported event cannot be definitively determined based on the available information.(b)(4).

Event Description

The user facility reported that the capiox device connector of sample line could not be fixed, easy to dis-connect during the priming.The event occurred pre-treatment, the patient was not harmed.The procedure outcome was not reported.

• Brand Name: CAPIOX FX 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: mary o'neill ; reg. no. 2243441; 950 elkton blvd.; elkton, MD 21921 ; 8002837866
• MDR Report Key: 12891647
• MDR Text Key: 282278868
• Report Number: 9681834-2021-00211
• Device Sequence Number: 1
• Product Code: DTZ
• UDI-Device Identifier: 04987350701022
• UDI-Public: 04987350701022
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K071494
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2024
• Device Catalogue Number: CX*FX25RE
• Device Lot Number: 210324
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2021
• Date Manufacturer Received: 11/01/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/24/2021
• 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