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

Catalog Number CX-FX15RW40V

Device Problems Leak/Splash (1354); Detachment of Device or Device Component (2907)

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

Event Date 11/30/2020

Event Type  malfunction  

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)- k130280.The actual sample was received for evaluation.Visual inspection revealed 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 sampling system to improve the lubricity of them in the manufacturing process.Reproductive testing was performed, and silicone was applied to a male connector of a factory-retained sampling system, a female connector was connected to it, and then a lock adapter was tightened up.As a result, the lock adapter came off.The factory-retained female connector was connected to the male connector of the actual sample, and then the sampling system was filled with normal saline and pressurized with syringe at 1000 mmhg.As a result, no leak occurred.Subsequently, while the lock adapter of the actual sample was put in the state of having got over the rib of the male connector, the sampling line was filled with normal saline.As a result, leak was observed at the joint between the male and female connector.From this, it was presumed that the joint between the male and female connectors became loose due to the dislodgement of the lock adapter, which resulted in the leak.A review of the device history record and 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 is 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 available information including the state of the actual sample, it could not be determined when silicone was transferred to the male connector.The exact cause of the reported event cannot be definitively determined based on the available information.(b)(4).

Event Description

The user facility reported that the involved capiox device was used pre-treatment.During priming, leak occurred at the luer locking part of the sampling system and the lock adapter came off.The sampling system was changed out to cope with the problem.The patient was not harmed.

• 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: theresa mussaw ; reg. no. 2243441; 265 davidson ave suite 320; somerset, NJ 08873 ; 8002837866
• MDR Report Key: 11001745
• MDR Text Key: 221270825
• Report Number: 9681834-2020-00251
• 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: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/14/2020

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: 03/31/2023
• Device Catalogue Number: CX-FX15RW40V
• Device Lot Number: 200429
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/01/2020
• Initial Date FDA Received: 12/14/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/29/2020
• 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