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

Catalog Number	CX*FX25RE
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/10/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Implanted date: device was not implanted.Explanted date: device was not explanted.The actual device was not returned; therefore, an evaluation of the actual device was unable to be conducted.A review of the device history record and product-release judgement record 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.It was likely that some kind of lubricant may have adhered to the male connector, which may have caused the lock adapter to come off when it was tightened.However, since the actual sample was not returned, confirmation of the presence of any adhering material could not be performed.With no device return 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 capiox device was used pre-treatment.The connector of sample line could not be fixed, easy to dis-connect during the priming.The user changed whole oxygenator by new one.The procedure outcome was not reported.The patient was not harmed.

• Brand Name: CAPIOX FX OXYGENATOR
• Common Device Name: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• MDR Report Key: 12539152
• Report Number: 9681834-2021-00173
• Device Sequence Number: 3990919
• Product Code: DTZ
• UDI-Device Identifier: 04987350701022
• UDI-Public: 04987350701022
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K071494
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/28/2021

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: 01/31/2024
• Device Catalogue Number: CX*FX25RE
• Device Lot Number: 210208
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/13/2021
• Initial Report FDA Received Date: 09/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1