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

Catalog Number CX-XRX24103

Device Problem Material Discolored (1170)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/23/2020

Event Type  malfunction  

Manufacturer Narrative

Implanted date: device was not implanted explanted date: device was not explanted 510k - k130520 the actual sample was received for evaluation.Visual inspection revealed that there was a cloudy white area around the 2000 ml-graduation on the reservoir.On the cloudy white area, there was deposit adhering to the inner surface.It was collected and subjected to elementary analysis by ft-ir.The ir spectra of the substance was fond to be similar to that of the thiopental, which is contained in anesthetics.The constituent substances and the manufacturing process of this product were reviewed and confirmed that no thiopental is used a review of the device history record and product release decision control sheet of the 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 white band-like streak the user pointed out was the deposit adhering to the inner surface of the reservoir.Since the substance similar to that contained in the deposit was confirmed not to be used for the product or in the manufacturing process of this product; the exact cause of the reported event cannot be definitively determined based on the available information.Terumo medical products (tmp) (importer) registration no.(b)(4).Is submitting this report on behalf of ashitaka factory of terumo corporation (manufacturer) registration no.(b)(4).

Event Description

The user facility reported that during priming of the involved capiox custom pack, a white band-like streak was seen around 2000 ml-mark of the venous reservoir.The outer surface was wiped; however, it did not disappear.It seemed to have occurred inside the reservoir.They continued using the oxygenator as it was without replacing it.The white band-like substance did not disappear even after the case was finished.The patient was not harmed.The procedure outcome was not reported.

Manufacturer Narrative

This report is being submitted as follow up no.1 to provide additional information in section b5.

Event Description

Additional information was received (b)(6) 2020.It was confirmed the event occurred during use, it did not occur during priming.

• 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: 10091178
• MDR Text Key: 240388817
• Report Number: 9681834-2020-00076
• 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: 05/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2021
• Device Catalogue Number: CX-XRX24103
• Device Lot Number: 191206
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2020
• Date Manufacturer Received: 06/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1