MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA CAPIOX RX25 OXYGENATOR; OXYGENATOR, CARDIOPULMONARY BYPASS

Catalog Number CX-RX25RW

Device Problem Material Separation (1562)

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

Event Date 12/07/2021

Event Type  malfunction  

Event Description

The user facility reported that the capiox device was used pre-treatment.The luer connector on the red cock side dislodged from the sampling system.The oxygenator was changed out.The patient was not harmed.The procedure outcome was not reported.

Manufacturer Narrative

Implanted date: device was not implanted.Explanted date: device was not explanted.Occupation- clinical engineer.The actual sample was received for evaluation.Visual inspection confirmed that the lock adapter had come off the male connector of the sampling system.Magnifying inspection of the actual sample did not find any visible anomaly, including deformity, in the male connector or in the lock adapter.The outer diameter of the rib of the male connector and the inner diameter of the lock adapter were measured.Compared to a current product sample, no difference was observed in the measured values.The surface of the male connector was subjected to elemental analysis by sem-edx (scanning electron microscope / energy dispersive x-ray spectroscopy).The result showed the presence of si, which is likely to be derived from the silicone applied to the switch cocks of the three-way stopcock to improve the lubricity of them in the manufacturing process.Simulation test: silicone was applied to a male connector of a factory-retained sampling system, a female connector was attached to it, and then a lock adapter was tightened up.As a result, the lock adapter came off the male connector.Product structure: the sampling system is designed so that the internal step of the lock adapter is hooked on the male connector's ribs to prevent loosening when the female luer is connected.Therefore, if the internal step completely overcomes the ribs for some reason, the mating may come off.A review of the device history record and the product-release judgement record 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 the silicon, which is applied to the switch cocks of the sampling system to improve the lubricity, was transferred to the male connector part due to some factors; therefore, it was likely that the lock adapter came off when it was re-tightened.However, from the state of the actual sample, the exact cause of the reported event cannot be definitively determined based on the available information.(b)(4).

• Brand Name: CAPIOX RX25 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: 13058968
• MDR Text Key: 289755680
• Report Number: 9681834-2021-00244
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K040210
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/22/2021

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: 07/31/2024
• Device Catalogue Number: CX-RX25RW
• Device Lot Number: 210802
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/07/2021
• Initial Date FDA Received: 12/22/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/02/2021
• 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