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

Catalog Number CX*FX05RW

Device Problem Leak/Splash (1354)

Patient Problem No Patient Involvement (2645)

Event Date 11/18/2019

Event Type  malfunction  

Manufacturer Narrative

Implanted date: device was not implanted.Explanted date: device was not explanted.510(k) no: k130280.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 involved product code/lot number combination revealed no findings.(b)(4).

Event Description

The user facility reported that the capiox device oxygenator was connected and the lines were primed.The perfusionist noticed a small leak.The oxygenator was replaced, and the system functioned 100%.There was no patient present, and no adverse event.This happened before the patient was brought in; therefore, there was no patient involvement.The perfusionists then changed the oxygenator and it worked perfectly.

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 no obvious anomaly that could lead to the leak, such as a break, in the appearance conditions.The actual sample was built into a circuit with tubing.Saline solution (colored for better visibility) was poured into the actual sample and then circulated.As a result, leak was found from both ends of the one-way valve incorporated in the purge line.Magnifying inspection of the actual sample revealed some cuts had occurred on both ends of the one-way valve.Electron microscopic inspection found that the cut surface of the cuts on both ends was smooth.This indicated that a sharp objected might have come into contact with those areas.In addition, the cuts on the reservoir side had some abrasions around it.Ifu states: do not use an oxygenator and reservoir that leaks.Replace it with another capiox fx05 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 a sharp tool came into contact with the one-way valve causing the cuts on both sides of it, resulting in the leakage.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: 9467252
• MDR Text Key: 196211720
• Report Number: 9681834-2019-00210
• Device Sequence Number: 1
• Product Code: DTZ
• UDI-Device Identifier: 04987350781772
• UDI-Public: 04987350781772
• Combination Product (y/n): N
• PMA/PMN Number: K071572
• 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: 12/13/2019

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 Expiration Date: 11/30/2021
• Device Catalogue Number: CX*FX05RW
• Device Lot Number: 181227
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2020
• Initial Date Manufacturer Received: 11/18/2019
• Initial Date FDA Received: 12/13/2019
• Supplement Dates Manufacturer Received: 01/09/2020
• Supplement Dates FDA Received: 02/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1