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

Catalog Number CX-FX25REV

Device Problem Material Separation (1562)

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

Event Date 10/14/2021

Event Type  malfunction  

Event Description

The user facility reported the capiox device was used during the procedure.When retightening after assembling the circuit, the red luer adapter of sampling system at the top of reservoir was reconnected.Using forceps, the ribs were forcibly overcome and reattached.The patient was not harmed.The procedure outcome was not reported.

Manufacturer Narrative

Expiration date - unknown due to unknown lot number.Udi - not required for product code.Implanted date: device was not implanted.Explanted date: device was not explanted.Occupation- clinical engineer.Device manufacturer date - unknown due to unknown lot number.The actual sample was received for evaluation.Visual revealed that the lock adapter was attached.Magnifying inspection of the actual sample found forceps marks generated when the lock adapter was reconnected.No anomaly such as a damage was found on the male connector.Simulation test: a factory-retained female connector was connected to the actual sample and was retightened.It was not possible to simulate the state in which the lock adapter was disconnected as described in the complaint.The force when tightening strongly by hand was measured.It was up to 50 newton centimeter.Then, using a tool, a force of 60 newton centimeter (50 newton centimeter or more) was applied to the actual sample to retighten it.It was not possible to simulate the state in which the lock adapter was disconnected.Product structure: the sampling system is designed that the internal step of lock adapter is caught on the rib of male connector so that it does not loosen when fitting with the female lure.Therefore, if the rib is completely overcome for some reason, the fitting may disconnect.The production lot number was not provided by the user facility, which prevented a meaningful review of the device history record.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.The actual sample was retightened, but the disconnection of lock adapter could not be simulated.As a possible cause of this complaint, it was likely that some kind of lubricant was attached to the male connector, and when the lock adapter was tightened, the lock adapter got over the rib of the male connector and disconnected.The exact cause of the reported event cannot be definitively determined based on the available information.(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
• 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: 12777810
• MDR Text Key: 282279670
• Report Number: 9681834-2021-00188
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K071572
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CX-FX25REV
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/15/2021
• Was Device Evaluated by Manufacturer?: Yes
• 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