MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA CAPIOX FX15 HOLLOW FIBER OXYGENATOR; BLOOD GAS OXYGENATOR

Catalog Number CX-XRY40801

Device Problem Coagulation in Device or Device Ingredient (1096)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/26/2015

Event Type  malfunction  

Event Description

The user facility reported thrombus found in the fx15 device.Follow up communication with the user facility reported the following information: a mvp+tap operation was conducted with capiox fx15; about three (3) hours after cpb on, and just after ao declamp, it was noted that a lot of thrombus was adhered inside the reservoir; the operation was continued and completed; there was no harm to the patient.

Manufacturer Narrative

The actual device was returned to the manufacturing facility for evaluation.Visual inspection upon receipt did not find any visible break on it.It was found that blood which had flowed out of the reservoir formed into thrombus at the suction ports.Visual inspection, after saline solution having been let to flow into the actual sample by gravity, revealed the thrombus formation on the lower parts of the vinous filter and cr filter around the solution level of 1000 - 1500ml.Electron microscopic inspection of the thrombus formed at the suction ports revealed agglutinated blood corpuscles.Electron microscopic inspection of the thrombus formed on the lower parts of the vinous filter and cr filter revealed agglutinated blood corpuscles.To check any plugging of the venous filter and the cr-filter, the actual sample was rinsed , dried and built into a circuit with the factory-reserved tubes.Then bovine blood was circulated in the venous filter and cr filter at the flow rate of 4l/min.For three (3) hours.The level of bovine blood in the venous filter was confirmed to be the same as that in the cr-filter.This indicates that either the venous filter or the cr filter has not gotten plugged.The actual sample was rinsed again and the venous filter was taken out of the reservoir for closer visual inspection.No anomaly was confirmed in the state of the filter-net with the presence of no break on it.Electron microscopic inspection of the venous filter did not reveal any anomaly in the state of the meshes.The cr filter was taken out of the reservoir for closer visual inspection.No anomaly was confirmed in the state of the filter-net with the presence of no break on it.On the portion where the thrombus had been adhering, the filter was found to have been discolored with pigmentation.Electron microscopic inspection of the cr filter did not reveal any anomaly in the state of the meshes, with no plugging or break.A review of the device history record of the involved product code/lot# combination confirmed there was no production related problem.A search of the complaint file did not find any other report of this nature with the involved product code /lot# combination.There is no evidence that this event was related to a device defect or malfunction.Although the exact cause cannot be determined based on the available information, the appearance of the involved sample is most consistent with blood in which coagulation factors had been activated was flowed into the reservoir and stagnated on the solution level, leading to the thrombus formation.The potential for such an event is addressed in the warning / precautions section of the instructions-for-use by statements such as "adequate heparinization of the blood is required to prevent it from clotting in the system", and "do not reduce heparin during circulation.Otherwise, blood clotting might occur." all available information has been placed on file in quality management for appropriate tracking, trending and follow up.(b)(4).

• Brand Name: CAPIOX FX15 HOLLOW FIBER OXYGENATOR
• Type of Device: BLOOD GAS OXYGENATOR
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, shizuoka 418 ; JA 418
• Manufacturer (Section G): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, shizuoka 418 ; JA 418
• Manufacturer Contact: kathleen little ; 950 elkton blvd.; elkton, MD 21921 ; 8002837866
• MDR Report Key: 4931579
• MDR Text Key: 6013911
• Report Number: 9681834-2015-00139
• 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
• Type of Report: Initial
• Report Date: 06/26/2015,07/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2017
• Device Catalogue Number: CX-XRY40801
• Device Lot Number: 150402
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2015
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 06/26/2015
• Device Age: 1 MO
• Event Location: Hospital
• Date Report to Manufacturer: 06/26/2015
• Date Manufacturer Received: 06/26/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/02/2015
• 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