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

Catalog Number CX-FX25REV

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/29/2019

Event Type  malfunction  

Manufacturer Narrative

Udi - not required for product code.Implanted date: device was not implanted.Explanted date: device was not explanted.510(k): k130520.The actual sample was received for evaluation.Visual inspection revealed that the lock adapter on the arterial side had been dislocated from the male connector.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 was measured and confirmed to be equivalent to those of a factory-retained current product sample.The male connector was subjected to elemental analysis of the surface using sem-edx (scanning electron microscope / energy dispersive x-ray spectroscopy).The result showed the presence of na and cl.On the cock of the three-way stopcock, elements such as si, which is considered to be derived from silicone applied to it to for improving the lubricity, were detected.It is presumed that the presence of na and cl was derived from the priming liquid adhered to the male connector during usage.Reproductive testing was performed, and silicone was applied to a male connector of a factory-retained 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.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.A review of the device history record and product release decision control sheet of the product code/lot# combination was conducted with no findings.Review of the current storage condition did not find any problem.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 sampling system components while stored in the container became overlapped by accident, and the silicone used for the cock part of the three-way stopcock was transferred to the male connector part.When the lock adapter was re-tightened, it got come off the male connector; the mating between the male connector and the female connector had been loose for some reason, the priming liquid slightly leaked became a lubricant.When the lock adapter was re-tightened, it got come off the male connector.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 the capiox device lock adapter on the arterial side of the sampling system was found broken during priming.The sampling system in question was replaced with another system the facility made by themselves to cope with the problem.There was no delay in starting the procedure, event occurred pre-treatment.No further issue was reported.There was no harm to the patient.The procedure was complete successfully.

• 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; 950 elkton blvd; elkton, MD 21921 ; 8002837866
• MDR Report Key: 9361609
• MDR Text Key: 220786306
• Report Number: 9681834-2019-00197
• 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: 11/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2022
• Device Catalogue Number: CX-FX25REV
• Device Lot Number: 190704
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/29/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/04/2019
• 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