MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA CAPIOX FX 15 HOLLOW FIBER OXYGENATOR AF

Catalog Number 1CX*FX15W

Device Problem Fracture (1260)

Patient Problem No Patient Involvement (2645)

Event Date 07/07/2016

Event Type  malfunction  

Manufacturer Narrative

The actual device has not been returned to the manufacturing facility for evaluation.For this reason, evaluation code was used in the conclusions.A follow up report will be submitted within 30 days of this report being sent.A review of the device history record and the product release decision control sheet of the involved product/lot # combination was conducted with no relevant findings.A search of the complaint file did not find any other report with the involved product code/lot# combination.(b)(4).All available information has been placed on file in quality assurance for appropriate tracking, trending and follow-up.Device not returned to manufacturer.

Event Description

The user facility reported a tube fracture on the capiox fx15 device during prime.Follow up communication with the user facility confirmed the following information: the one way valve line connected to the oxygenator looks like it had been severed; the product was changed out; the surgery was completed successfully; and there was no patient involvement.

Manufacturer Narrative

This report is being submitted as follow up # 1 to provide the returned sample evaluation results.The actual device was returned to the manufacturing facility for evaluation.Visual inspection confirmed the customer's observation.The purge line tube had been almost fractured at the joint with the port.Electron microscopic inspections of the fracture cross-sections of the tube found that some segments were in the smooth state and other segments in the rough state.It was noted that some streaks were generated starting from the smooth surface toward the rough surface.The tube was cut vertically and was subjected to another visual inspection revealing no defects, with the tube in the intact state.Simulation testing was conducted on a current product sample.A current product sample was exposed to a shock force at the joint of the purge line tube and the port after being left under a low temperature of 4°c.The sampling line tube became fractured at the joint.Electron microscopic inspection of the fractured cross-section found that the state of the surface was similar to that of the actual sample.A review of the device history record of the involved product code/lot# combination was conducted with no relevant findings.A search of the complaint file found no other report 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 cannot be definitively determined based on the investigation results, it is likely the actual sample was subjected to a shock force.The device labeling does address the potential for such an event in the instructions-for-use (ifu): "do not use if the package or device is damaged (e.G.Cracked) or any of the part caps are off.Do not use an oxygenator that leaks." all available information has been placed on file in quality assurance for appropriate tracking, trending and follow-up.

• Brand Name: CAPIOX FX 15 HOLLOW FIBER OXYGENATOR AF
• 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: 5840971
• MDR Text Key: 51004518
• Report Number: 9681834-2016-00191
• Device Sequence Number: 1
• Product Code: DTZ
• UDI-Device Identifier: 04987350701206
• UDI-Public: 04987350701206
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K071494
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 11/30/2018
• Device Catalogue Number: 1CX*FX15W
• Device Lot Number: 151216
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/04/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/16/2015
• 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
• Patient Outcome(s): Hospitalization