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

Catalog Number CX-XRX63201A

Device Problem Coagulation in Device or Device Ingredient (1096)

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

Event Date 11/05/2021

Event Type  malfunction  

Event Description

The user facility reported that the capiox device was used and after the surgery and before cleaning up the inside of the circuit, they saw what looked like a blood clot inside the oxygenator.They cleaned the inside of it and sealed it with a tube.The patient was not harmed.The procedure outcome was not reported.

Manufacturer Narrative

Udi - not required for product code.Implanted date: device was not implanted.Explanted date: device was not explanted.Occupation- clinical engineer.Pma/510(k)- k130520.The actual sample was received for evaluation.The provided picture showed that the filter was partially loose.A membranous clot-like substance was found inside the oxygenator.Visual inspection of the actual sample upon received found no breakage or no other external anomalies.The loose filter observed in the provided picture was not confirmed in the actual sample.The actual sample was rinsed with normal saline flowed by head, and then the oxygenation module was inspected visually.The membranous clot-like substance was found in the same position as that shown in the provided picture.In addition, not only that area, but the entire circumference was in the same condition.The actual sample was fixed with glutaraldehyde-containing normal saline, and then the housing and the filter were removed.Visual inspection of the filter found formation of blood clots on both the outer and the inner surfaces.Condition of the fiber bundle was checked when the filter was removed and when the half of the fiber layer was removed.Formation of blood clots were observed but the amount was small, therefore, it was presumed that the loose filter was not caused due to the formation of blood clots.The heat exchanger was removed from the outer cylinder and inspected visually.No formation of blood clots was observed.Electron microscopic inspection of the filter found formation of fibrin net and adhesion of blood components including erythrocytes, leukocytes, and platelets.Regarding the loose filter, it was assumed that it was caused due to air entered the oxygenator was trapped in the filter while blood inside the circuit was being collected.Based on this assumption, bovine blood was circulated inside a current product sample, and then the blood left inside the circuit was collected while bringing air into the oxygenator.As a result, it was confirmed that a part of the filter became loose.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 reduce heparin during circulation.Otherwise, blood clotting might occur.Adequate heparinization of the blood is required 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 formation of a blood clots was observed on the filter, and the electron microscopic inspection of the filter found the adhesion of blood components including erythrocytes, leukocytes, and platelets.As for the partially loose filter, it was presumed to have caused when air might have entered in the oxygenator while the blood left in the circuit was being collected after the procedure.The exact cause of the reported event cannot be definitively determined based on the available information.(b)(4).

• Brand Name: CAPIOX CUSTOM PACK
• 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; 265 davidson ave suite 320; somerset, NJ 08873 ; 8002837866
• MDR Report Key: 12932561
• MDR Text Key: 282279775
• Report Number: 9681834-2021-00222
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K071494
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2022
• Device Catalogue Number: CX-XRX63201A
• Device Lot Number: 210414
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/08/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/14/2021
• 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