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

Catalog Number 1ZZ*FX25RE

Device Problems Break (1069); Device Difficult to Setup or Prepare (1487)

Patient Problem No Patient Involvement (2645)

Event Date 12/05/2019

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 device has not been returned for evaluation.The investigation is currently ongoing.A follow up report will be submitted once the investigation is complete.A review of the device history record and product release decision control sheet of the product code/lot# combination was conducted with no findings.(b)(4).

Event Description

The user facility reported that air came into the lines during priming of the involved capiox device.They realized that the yellow key at the sampling piece was broken.The event occurred pre-treatment, there was no patient involved.

Manufacturer Narrative

This report is being submitted as follow up no.1 to provide the device return date in section d10, update section h3, and to provide the completed investigation results.The actual sample was received for evaluation.Visual inspection revealed a crack had occurred on the root of the female luer connector located between the yellow and blue cocks, and the blue cock side had come off the cradle.An attempt to inject colored saline solution into the actual sample with syringe demonstrated that the saline solution leaked from the crack.Subsequently, when the saline solution was aspirated with syringe, air was drawn through the crack into the actual sample.Magnifying inspection with ccd found whitening phenomenon (fine crazing) around the starting point of the crack.It may occur when resin material is subjected to external force and stretched.Based on the dislocation of the blue cock side from the cradle and the whitening phenomenon around the crack, it is likely that when attempting to remove the sampling system from the reservoir, they pulled up the blue cock side diagonally, and this caused the root of the female luer connector on the yellow cock to be exposed to bending force, resulting in the generation of the crack.Reproductive testing was performed using factory-retained sampling system samples.As a result, it was found that a crack occurred sometimes on the same location as the crack on the actual sample.In addition, magnifying inspection of the cracked section observed that whitening phenomenon occurred.Ifu states: do not use if the package or device is damaged (e.G.Cracked) or any of the port caps are off.Do not use an oxygenator and reservoir that leaks.Replace it with another capiox fx25 oxygenator and reservoir.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 was subjected to bending force while being removed from the reservoir, resulting in the generation of the crack.Due to the crack, it was likely that air was drawn in the line.However, the exact cause of the reported event cannot be definitively determined based on the available information.

• 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
• MDR Report Key: 9552613
• MDR Text Key: 205521505
• Report Number: 9681834-2019-00229
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• PMA/PMN Number: K071494
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2020
• Device Catalogue Number: 1ZZ*FX25RE
• Device Lot Number: 180912
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2020
• Date Manufacturer Received: 02/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1