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

Catalog Number 1ZZ*FX05REA

Device Problem Coagulation in Device or Device Ingredient (1096)

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

Event Date 09/08/2021

Event Type  malfunction  

Manufacturer Narrative

Implanted date: device was not implanted; explanted date: device was not explanted.Occupation- ccp.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.For this reason, investigation conclusions code has been referenced.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 white clots forming outside of the capiox device fiber bundle of oxygenator.The event was found while patient was on bypass.The product was not changed out, and they continued using the oxygenator.There was no delay in the procedure, no blood loss, no patient injury.The surgery/procedure was completed successfully.Additional information was receive on 10-sep-2021.The perfusionist stated "a buddy of mine helped my figure out those globules, they may be fractured/ denatured vwf (von willebrand factor).Could this occur with certain, rare susceptible kids with higher flows (1.5 - 2.0 lpm) on the fx05? unconfirmed but plausible to further investigate." vwf is a blood glycoprotein involved in hemostasis.Under high shear conditions, it promotes platelet aggregation.Additional information was received on 11-sep-2021.Product was not changed out, nothing was done.Ccp continued the case with 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 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 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 after blood drainage showed white clots-like substances adhering on the oxygenation module.Visual inspection of the actual sample as received found that it had been cleaned thus no adhesion of white-clots-like substance was confirmed.No breakage was observed in the actual sample.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.Subsequently, 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.The foreign substance pointed out in this complaint (white clots observed in the provided image) could not be confirmed in the actual sample.During the circulation test, no anomalies were observed in the actual sample.In addition, no problem was noted in the manufacturing records.Since the actual sample; foreign object (white-clots-like substance ) was not available for analysis 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: 12576622
• MDR Text Key: 281928123
• Report Number: 9681834-2021-00172
• 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: 10/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2023
• Device Catalogue Number: 1ZZ*FX05REA
• Device Lot Number: 140760
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2021
• Date Manufacturer Received: 10/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1