MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA CAPIOX FX15; OXYGENATOR, CARDIOPULMONARY BYPASS

Catalog Number	CX*FX15RW30
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Information (3190)
Date of Event	08/12/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Implanted date: device was not implanted.Explanted date: device was not explanted.Pma/510(k)- k130520.The actual sample was not returned for evaluation.An image showing the reported complaint was provided for review.A review of the image found that the sampling system had been deformed partially with the red stopcock having come apart from the tray it had sat in.It was noted that the sampling system had been primed and the stopcocks had been operated.The retention sample from the involved product code/lot# was evaluated.Visual inspection revealed there was no anomalies.Reproductive testing was performed.An attempt to lift up the reservoir was made by holding the red stopcock side of the sampling system and lifting up the sampling system diagonally.Consequently, the sampling system was subjected to bending force, resulting in the occurrence of the damage which was similar to that shown in the provided image.A review of the device history record and product release decision control sheet of the involved product code/lot number combination was conducted with 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 bending force during handling of the actual sample, resulted in the reported deformation on the sampling system.However, with no return 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 there was a problem with the involved capiox device.One of the red port had a problem, they were concerned that there would be problem during operation, this port is used to administer the drugs.The event occurred pre-treatment; the procedure outcome and patient impact was not reported.

• Brand Name: CAPIOX FX15
• Common Device Name: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• MDR Report Key: 8964738
• Report Number: 9681834-2019-00157
• Device Sequence Number: 2609376
• Product Code: DTZ
• UDI-Device Identifier: 04987350701169
• UDI-Public: 04987350701169
• Combination Product (Y/N): N
• Initial Reporter Country: ID
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 09/05/2019

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: 01/31/2022
• Device Catalogue Number: CX*FX15RW30
• Device Lot Number: 190206
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/12/2019
• Initial Report FDA Received Date: 09/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BLOOD LINE CSS
• Patient Age: 70 YR
• Patient Weight: 50