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

Catalog Number ZZ*FX25E

Device Problem Material Separation (1562)

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

Event Date 08/18/2021

Event Type  malfunction  

Manufacturer Narrative

Udi: not required for product code.Implanted date: device was not implanted.Explanted date: device was not explanted.Occupation: chief perfusionist.Phone number: requested, not provided.Pma/510(k): k130520.The actual device has not been returned for evaluation.The investigation is currently ongoing.A follow up report will be submitted once the investigation is complete.For this reason, investigation conclusions code (b)(4) has been referenced.A review of the device history record and product-release judgement record of the involved product code/lot# combination was conducted with no findings.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 reported that the capiox device was used pre-treatment.The luer lock was loose, it was the very left one beside the red of the manifold.The procedure was not delayed.The involved device was replaced to another supplier's device.Following the event, the patient has been treated as intended.The patient was not harmed.The procedure outcome was not reported.

Manufacturer Narrative

This report is being submitted as follow up no.2 to provide an update to the device return date in section d9, and provide the completed investigation results.It was reported in follow up no.1 that the actual sample was not available; however, the sample was received.The actual sample was received.Visual inspection revealed that the lock adapter had come off the male connector of the sampling system.Magnifying inspection of the actual sample found no deformity or other visible anomaly 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 with a factory-retained 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 connected to it, and then a torque load was applied to the lock adapter.As a result, the lock adapter came off.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.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.Afterward, the lock adapter, when re-tightened, may have got over the rib of the male connector in lubricated state and came off.However, from the state of the actual sample, the exact cause of the reported event cannot be definitively determined based on the available information.

Manufacturer Narrative

This report is being submitted as follow up no.1 to provide an update to the device return date in section d9, update section h3, and to provide the completed investigation results.It was initially reported that the actual sample was available; however, it was confirmed to no longer be available.The actual device was not returned; therefore, an evaluation of the actual device was unable to be conducted.No abnormality was found in the manufacturing records or the product-release judgement record.Based on experience, it was conceivable that some kind of lubricant may have adhered to the male connector, which may have caused the lock adapter to come off when the lock adapter was tightened.However, with no device return the exact cause of the reported event cannot be definitively determined based on the available information.

• 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: mary o'neill ; reg. no. 2243441; 950 elkton blvd.; elkton, MD 21921 ; 8002837866
• MDR Report Key: 12466204
• MDR Text Key: 271274410
• Report Number: 9681834-2021-00160
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: SZ
• 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,Followup,Followup
• Report Date: 09/14/2021

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: 08/31/2023
• Device Catalogue Number: ZZ*FX25E
• Device Lot Number: 200904
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/24/2021
• Initial Date FDA Received: 09/14/2021
• Supplement Dates Manufacturer Received: 11/09/2021; 12/06/2021
• Supplement Dates FDA Received: 11/22/2021; 12/22/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/04/2020
• 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