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

Catalog Number 1ZZ*FX15WA

Device Problem Leak/Splash (1354)

Patient Problem No Patient Involvement (2645)

Event Date 08/25/2016

Event Type  malfunction  

Manufacturer Narrative

The actual device has not been returned to the manufacturing facility for evaluation.For this reason, 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.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 the purge port on the oxygenator leaked during prime.Follow up communication with the user facility confirmed the following information: 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 no.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 located on the upper part of the oxygenator.There were no other anomalies on the remainder of the device.Magnifying and 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.There were no embedded foreign particles or entrainment of air bubbles which would have contributed to the generation of the fracture.The purge line tube was cut vertically and subjected to dimensional inspection and confirmed to meet manufacturer specification.Simulation testing was conducted on a current product sample.The current product sample was exposed to a shock force at the joint of the tube and the oxygenator outlet port after having been left under a low temperature of 4°c for 12 hours.The purge 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 that of the actual sample.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 occurrence in the instruction for use (ifu) with the statement such as the following: (1) "do not use if the package or device is damaged (e.G.Cracked) or any of the port caps are off." (2) "do not use an oxygenator that leaks." all available information has been placed on file in quality assurance at the manufacturing facility 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: 5971382
• MDR Text Key: 55456116
• Report Number: 9681834-2016-00227
• Device Sequence Number: 1
• Product Code: DTZ
• 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: 09/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 08/31/2018
• Device Catalogue Number: 1ZZ*FX15WA
• Device Lot Number: 150903
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/04/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/03/2015
• 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