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

Catalog Number CX-XRX21402

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Patient Involvement (2645)

Event Date 12/04/2019

Event Type  malfunction  

Manufacturer Narrative

Udi - not required for product code.Implanted date: device was not implanted.Explanted date: device was not explanted.510k - k130520.The actual sample was returned for evaluation.Visual inspection revealed that the lock adapter had detached from 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 dimensions of each part of the actual sample were measured and confirmed to be equivalent to those of a factory-retained current product sample.The surface of the male connector was subjected to elemental analysis using sem-edx (scanning electron microscope / energy dispersive x-ray spectroscopy).The result showed the presence of some elements, such as si, which are considered to be derived from the silicone that had been applied to 3-way stopcock to improve the lubricity of the cock in the manufacturing process.A reproductive test was conducted, and silicone was applied to a male connector of a factory-retained sampling system sample, then a female connector was attached to it and the lock adapter was tightened up.The result showed that the lock adapter could come off the male connector.A review of the device history record and product release decision control sheet of the product code/lot# combination was conducted with no findings.Product structure: the male connecter and the lock adapter of the sampling system fit with each other by the rib on the male connecter being caught with the stepped part provided inside the lock adapter.Due to this structure, once the lock adapter gets over the rib completely for some reason, it may come off the male connector.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 applied to the cock part of the three-way stopcock was transferred to the male connector part when the sampling system components were put in a container during manufacturing.Afterward, when the lock adapter was re-tightened, the lock adapter got over the rib on the male connector in lubricated state and dislocated.However, 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 during priming of the involved capiox custom pack, they found that male connector had detached from the sampling system on the top of the reservoir.The event occurred pre-treatment.

• 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; 2101 cottontail ln.; somerset, NJ 08873 ; 8002837866
• MDR Report Key: 9528695
• MDR Text Key: 205523201
• Report Number: 9681834-2019-00225
• 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: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2021
• Device Catalogue Number: CX-XRX21402
• Device Lot Number: 190911
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/04/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/11/2019
• 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