MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA CAPIOX FX25 HOLLOW FIBER OXYGENATOR AF; OXYGENATOR, CARDIOPULMONARY BYPASS

Catalog Number CX*FX25E

Device Problems Device Damaged Prior to Use (2284); Out-Of-Box Failure (2311)

Patient Problem No Patient Involvement (2645)

Event Date 03/09/2017

Event Type  malfunction  

Manufacturer Narrative

The actual device has been returned to the manufacturing facility for evaluation.The investigation is currently ongoing.A follow up report will be submitted once the investigation is complete.For this reason, (b)(4) has been referenced in the conclusions section of evaluation codes.A review of the device history records and product release decision control sheet 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.(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 the temperature port was found broken when removed from box.Follow up communication with the user facility reported the following information: there was no patient involvement.

Manufacturer Narrative

This report is being submitted as follow up number 1 to provide the returned device evaluation results.Visual inspection found the thermistor probe on the outlet port had been broken off.Magnifying inspection of the thermistor probe confirmed that it had not been deformed.The actual sample was filled with saline solution.With the blood outlet port clamped pressure was applied to the actual sample from the blood pathway for 6 hours.No leak was confirmed.Visual inspections under magnification and electron microscope of the fracture cross section confirmed there was no embedded particle which would deteriorate the product strength.On the surface, some parts were in the smooth state and other parts were in the rough state.On the smooth surface, the presence of some streaks was found.Simulation testing was conducted.A sample pulled from the current production run was subjected to an instantaneous shock force on the thermistor probe.The probe became fractured.Subsequent electron microscopic inspection of the fracture cross-section found that the surface on the side the shock force had been applied was in the smooth state and the surface on the opposite side was in the rough state.On the smooth surface some streaks going toward the rough surface were found to have been generated.On the surface of the thermistor probe, there was not any deformation.The damage to the actual sample was duplicated.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 actual sample was exposed to some shock force which exceeded the product's strength limit on the thermistor probe resulting in the reported event.The device labeling does address the potential for such an event in the instruction for use (ifu) with the statement such as the following: "do not use if the package or device is damaged (e.G.Cracked) or any of the port caps are off." 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 FX25 HOLLOW FIBER OXYGENATOR AF
• 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: jennifer suh ; reg. no. 2243441; 2101 cottontail ln.; somerset, NJ 08873 ; 8002837866
• MDR Report Key: 6465211
• MDR Text Key: 72127435
• Report Number: 9681834-2017-00066
• Device Sequence Number: 1
• Product Code: DTZ
• UDI-Device Identifier: 04987350701060
• UDI-Public: (01)04987350701060(17)191031(10)161111
• 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: 04/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2019
• Device Catalogue Number: CX*FX25E
• Device Lot Number: 161111
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/03/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/11/2016
• 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