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

Catalog Number 1ZZ*FX05RWA

Device Problem Coagulation in Device or Device Ingredient (1096)

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

Event Date 08/11/2021

Event Type  Injury  

Manufacturer Narrative

Implanted date: device was not implanted.Explanted date: device was not explanted.Occupation- perfusionist.Phone number- requested, not provided.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 an unusual looking substance on the oxygenator.The event was found during cardiopulmonary bypass, there was no reported delay.The product was changed out but did not have to go back on the pump.The surgery was completed successfully with no adverse event reported and there were a few cc of blood loss on the oxygenator.

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.H6: investigation findings - 114 is based upon the evaluation of user facility information and the investigation of the provided image; 213 is based upon functional testing of the returned sample.H6 - investigation conclusion - 4310 is based upon evaluation of the user facility information and the investigation of the provided image; 67 is based upon functional testing of the returned sample.The actual sample was received for evaluation.The provided image of the actual sample showed white clots-like substance adhering on the backside of the oxygenator.Visual inspection of the actual sample revealed that it had been cleaned thus no adhesion of white clots-like substance was confirmed.No breakage was observed in the actual sample.Blood had penetrated into the gap of gas-in side housing.The actual sample after rinsed and dried (was built into a circuit with tubing, and then the pressure drop was determined while bovine blood (hct 35% and temp.37°) was circulated in the circuit at each flow rate.The obtained values were confirmed to meet the factory's specifications.No blockage or other anomalies that could lead to blood clot formation were confirmed.After the inspection, blood channel was flushed with normal saline.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.Do not reduce heparin during circulation.Otherwise, blood clotting might occur.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 investigation results verified the returned sample was of normal product.According to the investigation results, the foreign substance pointed out in this complaint (white clots observed in the provided image) could not be confirmed in the actual sample, therefore the analysis of it could not be performed.No anomaly was found in the circulation test results or in the manufacturing related records.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
• MDR Report Key: 12420394
• MDR Text Key: 269741007
• Report Number: 9681834-2021-00154
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• PMA/PMN Number: K071572
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 09/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2023
• Device Catalogue Number: 1ZZ*FX05RWA
• Device Lot Number: 201124
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other