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

Catalog Number 1CX*FX15W

Device Problem Device Damaged Prior to Use (2284)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The actual device has not been returned to the manufacturing facility for evaluation.A follow up report will be submitted within 30 days of this report being sent.(b)(4).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 that during prime the sampling line connection at the arterial line outlet was damaged on the capiox fx15 device.Follow up communication with the user facility confirmed the following information: (1) the oxygenator was changed out before the case; (2) surgery was completed successfully; and (3) there was no patient involvement.

Manufacturer Narrative

This report is being submitted as follow up no.1 for mfg.Report no.9681834-2016-00004 to provide the retention sample evaluation results.The actual sample was not returned to the manufacturer for evaluation.Therefore, the investigation was based on evaluation of user facility information, and retention samples from product code 1cx*fx25w lot number 150615.Visual evaluation revealed no defects.The package configuration revealed that the joint between the blood out let port and the sampling line tube does not come into contact with any package materials.The retention sample was verified to be the normal product with no anomaly on the sampling tube.There is no evidence that this event was related to a device defect or malfunction and the exact cause cannot be determined.All available information has been placed on file in quality assurance for appropriate tracking, trending and follow-up.

Event Description

This report is being submitted as follow up no.1 for mfg.Report no.9681834-2016-00004 to provide the retention sample evaluation results.

Manufacturer Narrative

As stated, this report is being submitted as follow-up no.2 for mfg.Report no.9681834-2016-00004 to provide the return sample evaluation results.The actual device has been returned to the manufacturing facility for evaluation.Visual inspection upon receipt confirmed the customer's observation.The sampling line tube had been fractured at the joint with the oxygenator outlet port.Magnifying inspection of the fracture cross-sections of the tube revealed no defects.The tube was cut vertically and subjected to dimensional testing and confirmed to meet manufacturer specifications.Electron microscopic inspection of the fracture cross-sections found that some segments were in the smooth state and other segments in the rough state and revealed no defects which would have contributed to the generation of the fracture.Functional testing was conducted and was able to reproduce the reported defect.This test was conducted on a sampling line tube of a current product sample and was exposed to a shock force at the joint of the tube and the oxygenator outlet port after having been exposed to a low temperature of 4 degrees c for 12 hours.The sampling line tube became fractured at the joint.Electron microscopic inspection of the fracture cross-section found that the state of the surface was similar to the cracked cross-section of the actual sample.There is no evidence that this event was related to a device defect or malfunction and the exact cause cannot be determined.Based on the investigation results, it is likely the actual sample was subject to a shock force in the state of being cooled by having been left under a low temperature resulting in the reported breakage of the tube, however, the definite cause of the complaint could not be determined.All available information has been placed on file in quality assurance at the manufacturing facility for appropriate tracking, trending and follow-up.

Event Description

This report is being submitted as follow-up no.2 for mfg.Report no.9681834-2016-00004 to provide the return sample evaluation results.

• 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: 5427165
• MDR Text Key: 37978008
• Report Number: 9681834-2016-00004
• 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,Followup
• Report Date: 02/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2018
• Device Catalogue Number: 1CX*FX15W
• Device Lot Number: 150615
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/09/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/15/2015
• 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