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

Catalog Number 1ZZ*FX15E

Device Problem Fracture (1260)

Patient Problem No Patient Involvement (2645)

Event Date 05/01/2016

Event Type  malfunction  

Manufacturer Narrative

The product code and lot number have not yet been confirmed and therefore the udi number is unknown at this time in the investigation.The actual device has not been returned to the manufacturing facility for evaluation.A follow up report will be submitted when the investigation is complete, but no later than 30 days from the date that this report was sent.(b)(4).All available information has been placed on file in quality assurance at the manufacturing facility for appropriate tracking, trending and follow-up.

Event Description

The user facility reported a fracture on the purge line tube of the capiox device.Follow up communication with the user facility confirmed the following information: after de-airing the system, priming fluid came out of the purge line where it attaches to the oxygenator; the device was replaced; the procedure was completed successfully; and there was no patient involvement.

Manufacturer Narrative

This report is being submitted as follow up # 1 to provide the sample evaluation results.The involved device was returned to the manufacturing facility for evaluation.Visual inspection confirmed the customer's observation.The purge line tube had been almost fractured off at the joint of the port.An adhesive substance was found to be adhering to the tube around the fracture.Ashitaka factory does not use an adhesive substance during the manufacturing process of this component.This product is built into the tubing pack by a tubing pack manufacturer.Magnifying inspection of the fracture cross-sections of the tube confirmed that there was no evidence of the tube having been stretched.The purge line tube was cut vertically and inspected under magnification.There was no embedded foreign particle or entrainment of air bubbles.Electron microscopic inspection of the fracture cross-sections found that some segments were in a smooth state and others in the rough state.On the smooth surface some streaks were found to have been generated.A review of the device history record of the involved product code/lot number combination was conducted with no relevant findings.A search of the complaint file did not find any other report of this nature with the involved product code/lot# combination.There is no evidence that this event was related to a device defect or malfunction.Although the exact cause of the reported event cannot be definitively determined the device labeling does address the potential for such an event in the instructions-for- use (ifu) with statements such as the following: "do not use if the package or device is damaged (e.G.Cracked) or any of the part caps are off." and " do not use an oxygenator that leaks." all available information has been forwarded to the manufacturing facility for appropriate tracking, trending and follow up.

• Brand Name: CAPIOX FX OXYGENATOR
• Type of Device: OXYGENATOR
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, shizuoka 418 ; JA 418
• Manufacturer (Section G): TERUMO CORPORATION, ASHITAKA; reg. no. 9681834; 150 maimaigi-cho; fujinomiya city, shizuoka 418 ; JA 418
• Manufacturer Contact: jennifer suh ; reg. no. 2243441; 2101 cottontail ln.; somerset, NJ 08873 ; 8002837866
• MDR Report Key: 5690736
• MDR Text Key: 46260309
• Report Number: 9681834-2016-00127
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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
• Type of Report: Initial,Followup
• Report Date: 06/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2018
• Device Catalogue Number: 1ZZ*FX15E
• Device Lot Number: 151022
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/01/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/22/2015
• 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