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

Catalog Number 1CX-FX15E

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/03/2019

Event Type  malfunction  

Manufacturer Narrative

Udi - n/a as this product code is not exported to the us market.Implanted date: device was not implanted.Explanted date: device was not explanted.Pma/510(k) number - k130520.The actual device was returned for evaluation.Visual inspection found no break or no other visible anomaly in the outside of the oxygenator housing.The blood inlet port was found wobbled.The housing on the blood inlet port side was removed.Visual and magnifying inspection found a crack had occurred on the root of the blood inlet port.Physiological saline solution was fed into the blood channel by gravity drop.As a result, leak from the crack was observed.The blood inlet port was separated from the main body completely by being given a small cut to the cracked part for the evaluation of the cracked surface under magnifier and sem.Two different types of damaged states were observed; smooth surface suggests that the crack occurred instantaneously, and a streak-like pattern suggests that the crack extended subsequently.The streak-like pattern was found extended starting from the bottom side of the oxygenator.From this, it is conceivable that the crack occurred when the bottom side of the oxygenator was exposed to shock force.A retention sample was inspected.Visual inspection of a factory-retained sample of the involved product code/lot# found no break or no other anomaly in the appearance.The housing on the blood inlet port side of the oxygenator was removed.Visual and magnifying inspection found no crack or no other anomaly in the appearance.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.Based on the provided information and investigation results, there is no definitive evidence that this event was related to a device defect or malfunction.Based on the investigation results it is likely that the shock force applied to the actual sample from the bottom side of it was exerted on the blood inlet port, resulting in the generation of the crack in it.However, the exact cause of the reported event cannot be definitively determined based on the available information.Terumo medical products (tmp) is submitting this report on behalf of ashitaka factory of terumo corporation (manufacturer) registration no.9681834.

Event Description

The user facility reported that after the capiox oxygenator and the tubing were connected, priming solution was found leaking around the oxygenator inlet port.The blood inlet port was found wobbled.The actual device was changed out.The patient was not harmed.

Manufacturer Narrative

This report is being submitted as follow up no.1 to correct the device manufacture date in section h4, as it was inadvertantly reported as 06jul2019 when the actual date should have been 06jun2019.Terumo medical products (tmp) is submitting this report on behalf of ashitaka factory of terumo corporation (manufacturer) registration no.(b)(4).

• Brand Name: CAPIOX FX OXYGENATOR
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• MDR Report Key: 9528925
• MDR Text Key: 214799022
• Report Number: 9681834-2019-00224
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 12/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2022
• Device Catalogue Number: 1CX-FX15E
• Device Lot Number: 190606
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2019
• Date Manufacturer Received: 01/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1