MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA CAPIOX FX 25; OXYGENATOR, CARDIOPULMONARY BYPASS

Catalog Number ZZ*FX25EA

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/15/2019

Event Type  malfunction  

Manufacturer Narrative

The actual device has not been returned for evaluation.The investigation is currently ongoing.A follow up report will be submitted once the investigation is complete.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.(b)(4).

Event Description

The user facility reported that the recirc line off was off of the capiox fx device.This occurred during setup.The device was changed out, and the procedure was completed successfully.There was no blood loss.

Manufacturer Narrative

This report is being submitted as follow up no.1 to update and to provide the completed investigation.It was initially reported that the actual device was available for evaluation; however, it was confirmed to no longer be available.Results 3252 is based upon the evaluation of user facility information and the investigation of the photograph; 213 is based upon investigation of the retention sample.Conclusion 4315 is based upon the evaluation of user facility information and the investigation of the photograph; 67 is based upon investigation of the retention sample.The actual device was not returned to the manufacturing facility for evaluation.However, two photographs were provided by the user facility.A review pf the photo showing the actual sample found that the purge line had been almost fractured off at the joint with the port on the oxygenator module.An inspection of the retention sample was performed.Visual inspection revealed no anomalies.The retention sample was filled with saline solution.With the blood outlet port side clamped, an air pressure of 2kgf/cm2 was applied to the blood phase from the blood inlet port.No leak was observed.The purge line tube was cut vertically at a point and the cut cross-section was inspected under magnification.There was no unevenness or deformation in the shape.The inside and outside diameters were confirmed to be comparable to those of the current product sample.Ifu states: do not use if the package or device is damaged (e.G.Cracked) or any of the port caps are off.Do not use an oxygenator that leaks.The involved device was not returned for evaluation.Therefore, the investigation was based on user facility information and evaluation of the unused samples.The retention sample was confirmed to be the normal product without having any anomaly which could relate to a fracture of the tube.It is likely that the actual sample was exposed to some shock force which exceeded the product's strength limit during transportation, storage or during the use by the customer.However, with no device return the exact cause of the reported event cannot be definitively determined based on the available information.

• Brand Name: CAPIOX FX 25
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, shizuoka 418 ; JA 418
• MDR Report Key: 8483035
• MDR Text Key: 140916541
• Report Number: 9681834-2019-00052
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• PMA/PMN Number: K071494
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 04/04/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2020
• Device Catalogue Number: ZZ*FX25EA
• Device Lot Number: 170515
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/15/2019
• Initial Date FDA Received: 04/04/2019
• Supplement Dates Manufacturer Received: 05/14/2019
• Supplement Dates FDA Received: 06/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1