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

Model Number N/A

Device Problem Material Separation (1562)

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

Event Date 08/05/2022

Event Type  malfunction  

Manufacturer Narrative

Patient identifier: requested, not provided.Age & date of birth: requested, not provided.Patient sex: requested, not provided.Weight: requested, not provided.Ethnicity: requested, not provided.Race: requested, not provided.Implanted date: device was not implanted.Explanted date: device was not explanted.Occupation: clinical engineer.Pma/510(k): k130280.Visual inspection of the actual sample found that the lock adapter had come apart from the male connector of the sampling system.Magnifying inspection of the actual sample did not find any anomaly such as a deformation on the male connector and the 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 microscopy/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.As a simulation test, 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 came off.Our sampling system is designed so that the internal step of lock adapter is caught on the ribs of the 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.Review of the manufacturing record and the shipping inspection record of the actual sample 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.The mechanism by which the silicone applied to the cock being transferred to the male connector was investigated.As a result, it was found that when the product was stored in a sealed state, the concentration of silicone volatilized in the peel pack increased, and it was transferred to other sections.In addition, it was inferred that the longer the period from the sampling system assembling process to the delivery to the oxygenator manufacturing process, the more silicone volatilized and transferred to other sections.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).

Event Description

The user facility confirmed that the luer lock of the sampling system came off.Since a prior similar event had occurred, a replacement part had been obtained and the device was replaced with that part.This issue was found during setup and the product was not used on the patient.The event occurred pre-treatment.The final patient impact was not harmed.

• 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: 15281918
• MDR Text Key: 298984365
• Report Number: 9681834-2022-00171
• 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: 08/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2022
• 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-FX25REV
• Device Lot Number: 220131
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/09/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/31/2022
• 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