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

Catalog Number CX-FX25RWV

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 01/24/2022

Event Type  malfunction  

Event Description

The user facility reported the capiox device involved priming was completed.When the red lock of sampling system was fastened, it did not lock and came off.This was resolved by attaching a three-way stopcock to the red lock.There was no medical or surgical intervention required.The patient was not harmed.

Manufacturer Narrative

Udi - not required for product code.Implanted date: device was not implanted.Explanted date: device was not explanted.Occupation-clinical engineer.Pma/510(k)- k071572, k130280.(b)(4).The actual device has been returned for evaluation.Visual inspection of the actual sample found that the lock adapter had been come off from the male connector of sampling system.Magnifying inspection of the actual sample did not find any anomaly including a deformation on the male connector and lock adapter.The outer diameter of the rib of male connector and the inner diameter of the lock adapter were measured and compared with a factory-retained product.No difference was found.Elemental analysis of the surface of actual male connector was performed by sem-edx (scanning electron microscope/energy dispersive x-ray spectroscopy).As a result, si was detected in the cock of involved three-way stopcock, which was likely to be derived from the silicone applied for the purpose of improving lubricity.A simulation test was conducted, after applying silicone to the male connector of factory-retained sampling system, the female connector was connected and applied torque force to the lock adapter.It was found that the lock adapter was come off.Product structure of our sampling system is designed so that the internal step of lock adapter is caught on the ribs of male connector to prevent loosening when the female luer is fixed.Therefore, if the internal step completely overcomes the ribs for some reason, the fixing may come off.A review of the manufacturing record and the product release decision control sheet of the actual product confirmed that there were not any indications of anomaly in them.A search of the complaint file found no other similar report with the involved product code/lot# combination.Manufacturing date: september 7, 2021 based on the investigation result, as a cause of occurrence, it was likely that silicone applied to the cock of sampling system for the purpose of improving lubricity was transferred to the male connector for some reason.Therefore, when the lock adapter was tightened, it came off.However, it was not possible to clarify the timing of the transfer of silicone to the male connector from the state of actual sample.Ifu states: do not use if the package or device is damaged (e.G.Cracked) or any of the port caps are off.(b)(4).

• 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: stephanie handy ; 950 elkton blvd.; elkton, MD 21921 ; 8002837866
• MDR Report Key: 13529506
• MDR Text Key: 288047170
• Report Number: 9681834-2022-00013
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K071572
• 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
• Report Date: 02/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CX-FX25RWV
• Device Lot Number: 210907
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/24/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/07/2021
• 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