MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA CAPIOX HOLLOW FIBER OXYGENATOR/ARTERIAL FILTER; OXYGENATOR, CARDIOPULMONARY BYPASS

Catalog Number CX-FX25REV

Device Problem Break (1069)

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

Event Date 04/25/2022

Event Type  malfunction  

Event Description

The user facility reported that part of the involved capiox device came off during set up.They found it during preparation and discontinued usage.They have experienced this issue previously and used a backup part.The surgery was finished with no problem.The actual sample was not exposed to sars-cov-2.There was no patient involvement.This event occurred pre-treatment.The procedure for the patient was completed successfully.The final impact of the patient was not harmed.

Manufacturer Narrative

Udi: na.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): k071572 & k130280.The actual device has been returned for evaluation.Visual inspection of the actual sample confirmed 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 three-way stopcock to improve the lubricity of them in the manufacturing process.Silicone was applied to a male connector of a factory-retained sampling system, a female connector was attached to it, and then a lock adapter was tightened up.As a result, the lock adapter came off the male.Our 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.Review of the manufacturing record and the product-release judgement record of the involved product code/lot number combination confirmed that there were not any anomalies in them.A search of the complaint file found no other similar reports with the involved product /lot number combination.The mechanism by which silicone applied to the stopcock transfers to the male connector part was investigated, and it was confirmed that, when the stopcock is stored in a sealed bag, the concentration of silicone that volatilized inside the bag increases and transfers to other parts.It is likely that the longer the time between the assembly process of the sampling system and its delivery to the oxygenator manufacturing process, the more silicone can volatilize and transfer to other parts.Relevant ifu reference: "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 HOLLOW FIBER OXYGENATOR/ARTERIAL FILTER
• 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: 14490844
• MDR Text Key: 293105196
• Report Number: 9681834-2022-00094
• 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: 05/24/2022

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 Catalogue Number: CX-FX25REV
• Device Lot Number: 211104
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/25/2022
• Initial Date FDA Received: 05/24/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/04/2021
• 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