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

Catalog Number CX*FX05RE

Device Problem Coagulation in Device or Device Ingredient (1096)

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

Event Date 12/13/2021

Event Type  malfunction  

Manufacturer Narrative

Implanted date: device was not implanted.Explanted date: device was not explanted.Phone number- requested, not provided.Occupation- chief perfusionist.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 small red clots that was visible on the side of the oxygenator membrane.The event occurred during cardiopulmonary bypass, there was no delay in the procedure, the product was not changed out and the surgery was completed successfully with no patient effect.There was no blood loss.

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 inspection of the actual sample as received found no breakage or other anomalies in the appearance.The actual sample had been cleaned, so the adhesion state of blood clots could not be checked.The actual sample after rinsed and dried was built into a circuit with tube, and then bovine blood (hct35% and temp.37°) was circulated in the circuit at each flow rate while the pressure drop was determined.The obtained values were confirmed to meet the factory's specifications.No anomaly, such as an obstruction in the flow path leading to the blood clot, was confirmed.No leak was observed in the gas-in and gas-out sides.After the circulation test, normal saline was flowed into the blood channel.As a result, no formation of blood clots was confirmed.Ifu states: adequate heparinization of the blood is required considering patient condition and perfusion technique to prevent it from clotting in the system.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 blood clots as reported were not confirmed in the actual sample and no anomaly was observed in the actual sample during the circulation test.In addition, no anomaly was noted in the manufacturing related records.As a cause of occurrence, the possibility that the blood clots formed due to some factors (such as the patient's blood condition) was presumed.However, 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: 13224830
• MDR Text Key: 287897976
• Report Number: 9681834-2021-00262
• Device Sequence Number: 1
• Product Code: DTZ
• UDI-Device Identifier: 04987350781758
• UDI-Public: 04987350781758
• 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: 01/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2022
• Device Catalogue Number: CX*FX05RE
• Device Lot Number: 191121
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/26/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/21/2019
• 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