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

Catalog Number CX*FX25RW

Device Problem Leak/Splash (1354)

Patient Problem No Patient Involvement (2645)

Event Date 09/18/2017

Event Type  malfunction  

Manufacturer Narrative

The actual device has been returned to the manufacturing facility for evaluation.Visual inspection found the purge line tube almost cut off the segment adjacent to the joint with the purge line tube on the oxygenator module.There was no other damage on the rest of the device.Magnifying and electron microscopic inspections of the cut cross section of the sampling line tube did not reveal any embedded foreign particle or entrainment of air bubbles which would have contributed to the generation of the fracture.It was revealed most area of the cut cross section was in a smooth state with the generation of characteristic streaks on it.Simulation testing was conducted.The state of the damage of the purge line tube of the actual device is experientially known to be consistent with the when the tube has come into contact with a sharp tool and became cut with it.The purge line tube of a current product sample was pinched and cut with a sharp tool.Electron microscopic inspection of the cut cross section revealed the smooth surface with the generation of characteristic streaks on it.The state of damage was very similar to the actual device.A review of the device history record and product release decision control sheet from the reported product code/lot number combination was conducted with no relevant findings.A search of the complaint file found (b)(4) similar report with the involved product code/lot number combination.Refer to mdr 9681834-2017-00216.There is no evidence that this event was related to a device defect or malfunction.While the exact cause of the reported event cannot be definitively determined based on the available information, it is likely the purge line was pinched and cut with a cutting tool resulting in the reported event.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 an oxygenator that leaks.(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 leak in the capiox device during priming.Follow up communication with the user facility confirmed the following information: the perfusionist found a leak at the end of purge line; the device was replaced with new fx25 to run the cpb; and there was no patient involvement.

• Brand Name: CAPIOX FX OXYGENATOR
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• 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: terry callahan ; reg. no. 2243441; 2101 cottontail ln.; somerset, NJ 08873 ; 8002837866
• MDR Report Key: 6943896
• MDR Text Key: 90298020
• Report Number: 9681834-2017-00217
• Device Sequence Number: 1
• Product Code: DTZ
• UDI-Device Identifier: 04983750701046
• UDI-Public: (01)04983750701046(17)200229(10)170321C
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K071494
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2020
• Device Catalogue Number: CX*FX25RW
• Device Lot Number: 170321C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/18/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/21/2017
• 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