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

Model Number	1CX*FX25W
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	11/13/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The actual sample was received for evaluation.Visual inspection revealed that the purge line tube had fractured at the joint with the port on the oxygenator.Magnifying and electron microscopic inspections of the fracture cross-section of the tube confirmed there was not any anomaly on the surface that could have been a trigger of the generation of the fracture with no embedded foreign substance or entrainment of air bubbles in the tube material.The surface was in the smooth state on some part and in the rough state on other part.On the smooth part, some streaks were found to have been generated.This streak pattern implies that the fracture occurred at one point and developed in the direction of the streak pattern.The tube was cut on the intact section and the cross section was inspected under a magnifier.No unevenness in the wall thickness was observed.The outer and inner diameter of the tube was measured and confirmed to be equivalent to those of a current product sample.Reproductive testing was performed taking in account based on the review of the temperature in st.Louis (mo), where the involved facility is located.It was found the daily lowest temperature had gone down to below freezing sometimes in the period from (b)(6) 2019, when the actual sample was manufactured, to (b)(6) 2019, when this complaint occurred.Multiple product test samples, after having been cooled down to 10°c below zero, were dropped from 1.5m high in the state of being packed in the box in the normal manner.The result showed that the tube of some of the samples became fractured at the joint with the product.A review of the device history record and product release decision control sheet of the involved product code/lot# 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 actual sample in a cooled state was exposed to excessive shock force during being handled, which resulted in the generation of the fracture in the purge line tube.It is presumed that the actual sample had been cooled due to low temperature during the transportation or storage in the cold season.However, 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 prime line on the capiox fx oxygenator was broken out of box.It was not noticed until prime solution was added at 8:00 am.The problem occurred out of the box.There was not a delay with the procedure due to the event.

• Brand Name: CAPIOX FX25 HOLLOW FIBER OXYGENATOR AF
• Common Device Name: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• MDR Report Key: 9438468
• Report Number: 9681834-2019-00207
• Device Sequence Number: 2474219
• Product Code: DTZ
• UDI-Device Identifier: 04987350701084
• UDI-Public: 04987350701084
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K071494
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/09/2019

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: 03/31/2022
• Device Model Number: 1CX*FX25W
• Device Catalogue Number: CX*FX25W
• Device Lot Number: 190411
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/13/2019
• Initial Report FDA Received Date: 12/09/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1