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

Catalog Number	CX*FX25RE
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	06/24/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Implanted date: device was not implanted.Explanted date: device was not explanted.510(k) - k130520.The actual sample was received for evaluation.Visual inspection revealed that the sampling system had been fractured at the joint between the male luer of the blue stopcock and the female luer of the yellow stopcock, with the fractured blue stopcock having come apart from the tray it had sat in.Magnifying inspection of the fracture cross-sections did not reveal any anomaly that could be a trigger of the fracture, including a foreign particle or air bubble embedded in the material.Reproductive testing was performed.The retention sample was exposed to shock force on the sampling system.The sampling system became fractured and the blue stopcock came off the tray it had sat in.The damage similar to that observed on the actual sample was duplicated.The sampling system was taken off the reservoir in the manner where the blue stopcock was held and pulled upward.The sampling system got fractured at the joint between the male luer of the blue stopcock and the female luer of the yellow stopcock.A review of the device history record and shipping inspection record of the involved product code/lot number combination revealed no findings.Ifu states: do not use if the package or device is damaged (e.G.Cracked) or any of the port caps are off.Based on the provided information and investigation results, there is no definitive evidence that this event was related to a device defect or malfunction.It is likely that the sampling system of the actual sample was exposed to some force which exceeded the strength limit of this product, resulting in the reported damage.However, from the state of the actual sample, the exact cause of the reported event cannot be definitively determined based on the available information.(b)(4).
Event or Problem Description
The user facility reported that the capiox device had a broken sampling system.The break was found after opened the tyvek bag.The event occurred pre-treatment.

• Brand Name: CAPIOX FX OXYGENATOR
• Common Device Name: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• MDR Report Key: 8846257
• Report Number: 9681834-2019-00137
• Device Sequence Number: 2337370
• Product Code: DTZ
• UDI-Device Identifier: 04987350701022
• UDI-Public: 04987350701022
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K071494
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2021
• Device Catalogue Number: CX*FX25RE
• Device Lot Number: 190110K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/18/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/05/2019
• Initial Report FDA Received Date: 07/31/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1