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

Catalog Number ZZ*FX25RW

Device Problem Fracture (1260)

Patient Problem No Patient Involvement (2645)

Event Date 07/05/2016

Event Type  malfunction  

Manufacturer Narrative

Udi no.- not required to be registered with fda.The actual device has been returned to the manufacturing facility and the evaluation is currently ongoing.A follow up report will be submitted within 30 days from the date that this report was sent.For this reason code was used in the conclusions.A review of the device history record and product release decision control sheet of the involved product/lot # combination was conducted with no relevant findings.A search of the complaint file found no report of this nature with the involved product/lot# combination.(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 tube fracture on the capiox device.Follow up communication with the user facility confirmed the following information: broken connector during packing; and there was no patient involvement.

Manufacturer Narrative

This report is being submitted as follow-up # 1 to provide the sample evaluation.Visual inspection found that the package cushion material had been deformed.It cannot be known when this damage was generated on the package.Visual inspection of the device found that the sampling line tube had been almost fractured at the joint with one of the ports on the venous blood inlet port located on the reservoir lid.There was no other anomalies noted.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.On the smooth surface, the generation of some streaks were noted.No embedded foreign particle or entrainment of air bubbles was noted which would have contributed to the generation of the fracture.The tube was cut vertically and subjected to dimensional checks.No anomalies were revealed.Simulation testing was conducted.A current product sample was exposed to shock force at the joint of the sampling line tube and the port after it having been left under a low temperature of 4 °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 very similar to that of the actual sample.There is no evidence that this event was related to a device defect or malfunction.The exact cause of the reported event cannot be definitively determined based on the available information, it is possible that the actual sample may have been 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 and reservoir 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 OXYGENATOR
• Type of Device: DIALYZER
• 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: 5833092
• MDR Text Key: 50738710
• Report Number: 9681834-2016-00183
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 07/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2019
• Device Catalogue Number: ZZ*FX25RW
• Device Lot Number: 160220
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/19/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/20/2016
• 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