MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA CAPIOX HOLLOW FIBER OXYGENATOR/ARTERIAL FILTER; OXYGENATOR, CARDIOPULMONARY BYPASS

Catalog Number 1CX*FX05RW

Device Problem Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/16/2021

Event Type  malfunction  

Manufacturer Narrative

Implanted date: device was not implanted.Explanted date: device was not explanted.Occupation- ccp.Phone number- requested, not provided.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# combination was conducted with no findings.(b)(4).

Event Description

The user facility reported that the outlet side of the capiox device oxygenator appeared deformed or melted.There was no procedure delay due to the event.The issue was found out of the box.

Manufacturer Narrative

This report is being submitted as follow up no.1 to provide the device return date in section d9, update section h3, and to provide the completed investigation results.The actual sample was received for evaluation.Visual and magnifying inspection of the actual sample focusing on the area pointed out in the complaint found that the blood outlet port was deformed inward, which suggested that an external load might have been applied to this part.The cap that had been attached to the blood outlet port was not returned for analysis.The actual sample was entirely inspected with unaided eye.A part of the oxygenator housing had been broken and the blood inlet port was deformed having broken through the blue cap and deformed.However, these breakages were considered to be different from the damage pointed out and therefore the causal link with the reported event could not be clarified.The same type of product was checked for the condition of the product inside the unit box (positional relationship between the oxygenator and buffer material).There was no contact between the blood outlet port and the buffer material.Simulation test: an impact load was applied to the cap attached to the blood outlet port of an oxygenator sample.As a result, the blood outlet port was crushed inward.In addition, trace of the inner surface of the cap having come into contact with the blood outlet port was observed.Since the cap of the actual sample was not returned to the factory, confirmation of such a trace on the actual sample could not be performed.Ifu states: if the product is dropped during set-up, do not use it.Replace with another device.Based on the provided information and investigation results, there is no definitive evidence that this event was related to a device defect or malfunction.The cause of the deformation of the blood outlet port may have been caused by the application of some kind of load to the blood outlet port.In the production process, the cap is attached to the blood outlet port after the 100% visual inspection.Since the unit box and the cap were not returned for analysis, it could not be clarified when the actual sample was exposed to an external load.The exact cause of the reported event cannot be definitively determined based on the available information.

• Brand Name: CAPIOX HOLLOW FIBER OXYGENATOR/ARTERIAL FILTER
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• Manufacturer (Section G): TERUMO CORPORATION, ASHITAKA; reg. no. 9681834; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• Manufacturer Contact: mary o'neill ; reg. no. 2243441; 950 elkton blvd.; elkton, MD 21921 ; 8002837866
• MDR Report Key: 12434108
• MDR Text Key: 270555101
• Report Number: 9681834-2021-00153
• Device Sequence Number: 1
• Product Code: DTZ
• UDI-Device Identifier: 04987350781772
• UDI-Public: 04987350781772
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K071572
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2023
• Device Catalogue Number: 1CX*FX05RW
• Device Lot Number: 201207
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/15/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/07/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1