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

Model Number N/A

Device Problem Device Damaged Prior to Use (2284)

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

Event Date 04/07/2022

Event Type  malfunction  

Event Description

The user facility reported that when setting up the oxygenator system of the capiox oxygenator involved, it was confirmed that the sampling line (sampling system connection) was damaged.The involved sampling line (sampling system) was replaced.

Manufacturer Narrative

Udi: n/a as this product code is not exported to the us market.Implanted date: device was not implanted.Explanted date: device was not explanted.Occupation: clinical engineer.Pma/510(k)- k130520.Visual inspection of the actual sample found that the lock adapter had been disconnected from the mal connector of the sampling system.Magnifying inspection of the actual sample did not find any anomaly including deformation in the male connector and the lock adapter.The outer diameter of the rib of actual male connector and the inner diameter of 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, the si was detected in the cock of the involved three-way stopcock, which was likely to be derived from the silicone applied for the purpose of improving lubricity.As a simulation test, silicone was applied to the male connector of the factory-retained sampling system, the female connector was connected and applied torque force to the lock adapter.It was found that the lock adapter came off.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, 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 number combination.Based on the investigation result, as a cause of occurrence, it was likely that silicone applied to the cock of the sampling system, for the purpose of improving lubricity, was transferred to the male connector.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.Relevant ifu reference: "do not use if the package or device is damaged (e.G.Cracked) or any of the port caps are off." 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).

• 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: stephanie handy ; reg. no. 2243441; 265 davidson ave suite 320; somerset, NJ 08873 ; 9499890491
• MDR Report Key: 14242500
• MDR Text Key: 290546819
• Report Number: 9681834-2022-00078
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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
• Report Date: 04/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: CX-FX15W
• Device Lot Number: 210914
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/14/2021
• 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