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

Catalog Number CX-FX25RE

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/26/2018

Event Type  malfunction  

Manufacturer Narrative

Implanted date: device was not implanted.Explanted date: device was not explanted.510(k): k130520.The actual sample was returned for evaluation.Visual inspection revealed that the lock adapter had come off the male connector and was missing.The lock adapter and the competitor's extension tube involved in this complaint were not returned for evaluation.Magnifying inspection of on the male connector, focusing on the section to be fitted to the lock adapter confirmed it had not been deformed.The adhesion of some white substances which appeared to be dried priming solution, was found.The white substances were removed and the outside diameter of the section to be fitted to the lock adapter on the male connector was determined.It was confirmed to meet the specifications.Reproductive testing was performed.A factory-retained sampling system was connected to an extension tube and the lock adapter was exposed to excessive torque force.The lock adapter came off the male connector.A review of the device history record and shipping inspection record of the involved product/lot# combination was conducted with no findings.Ifu states: do not use if the package and/or device is damaged or if caps are not in place.There is no evidence that this event was related to a device defect or malfunction.Based on the investigation results, it is likely that the lock adapter of the actual device was exposed to excessive torque force and came off the main body, resulting in the reported difficulty in firm connection of the competitor's extension tube to the actual device.However, the exact cause of the reported event cannot be definitively determined based on the available information, and with the absence of the actual lock adapter, and the competitor's extension tube to evaluate.(b)(4).

Event Description

The user facility reported that the involved capiox device lock adapter was not working properly, making it difficult to fix a competitor's extension tube firmly to the male connector on the red stopcock side of the actual sample.The customer used the actual sample till the end of the case without changing it out, and the procedure was completed successfully.The patient was not harmed.

• Brand Name: CAPIOX FX OXYGENATOR
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, shizuoka 418 ; JA 418
• Manufacturer (Section G): TERUMO CORPORATION, ASHITAKA; reg. no. 9681834; 150 maimaigi-cho; fujinomiya city, shizuoka 418 ; JA 418
• Manufacturer Contact: mark vornheder ; reg. no. 2243441; 950 elkton blvd.; elkton, MD 21921 ; 8002837866
• MDR Report Key: 8173495
• MDR Text Key: 131781214
• Report Number: 9681834-2018-00224
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K071494
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2021
• Device Catalogue Number: CX-FX25RE
• Device Lot Number: 180203
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/27/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/03/2018
• 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