MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA CAPIOX FX25 OXYGENATOR; OXYGENATOR, CARDIOPULMONARY BYPASS

Catalog Number CX*FX25RW

Device Problem Decrease in Pressure (1490)

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

Event Date 12/22/2020

Event Type  malfunction  

Manufacturer Narrative

Device expiration date - unknown due to unknown lot number.Implanted date: device was not implanted.Explanted date: device was not explanted.Device manufacturer date - unknown due to unknown lot number.Occupation- chief perfusionist.Pma/510(k)- k130520.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.The production lot number was not provided by the user facility, which prevented a meaningful review of the device history record.(b)(4).

Event Description

The user facility reported that the capiox device was used pre-treatment.Chief perfusionist: pressure alarm at a flow of 4.5 liters during the priming phase.Priming volumes: 1500ml jonosteril (carbohydrate electrolyte solution) 250ml / 15% mannitol solution 40ml / 8.4% sodium hydrogen carbonate 10.000 heparin complete hlm & set exchanged terumo tubing pack set: cxge272 / lot#: 2006330.The patient was not harmed.The procedure outcome was not reported.

Manufacturer Narrative

This report is being submitted as follow up no.1 to provide the completed investigation results.It was initially reported that the actual device was available for investigation; however, it was confirmed the device was not available.Therefore, sections d9 and h3 have been updated to reflect the device is not available.The actual device was not returned; therefore, an evaluation of the actual device was unable to be conducted.With no device return the exact cause of the reported event cannot be definitively determined based on the available information.

Manufacturer Narrative

This report is being submitted as follow up no.2.This reported event has been deemed not reportable based off the actual sample that was received on (b)(6) 2021.The product code was confirmed to not be cx*fx25rw as initially reported, and therefore is not reportable.

• Brand Name: CAPIOX FX25 OXYGENATOR
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• MDR Report Key: 11192336
• MDR Text Key: 280446572
• Report Number: 9681834-2020-00273
• Device Sequence Number: 1
• Product Code: DTZ
• UDI-Device Identifier: 04987350701046
• UDI-Public: 04987350701046
• 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,Followup
• Report Date: 01/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CX*FX25RW
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1