MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA CAPIOX FX25 HOLLOW FIBER OXYGENATOR AF; OXYGENTOR

Catalog Number CX-FX25RW

Device Problem Coagulation in Device or Device Ingredient (1096)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/03/2015

Event Type  malfunction  

Manufacturer Narrative

The actual device was returned to the manufacturing facility for evaluation.Visual inspection upon receipt found the formation of red thrombus on the lower part of the venous filter.The adhesion of blood was noted up to the solution level of around 1500ml.There was no visible break on it.The cr filter and the de-bubbling material housed in the cr filter were taken out of the reservoir for further inspection.Visual inspection of the inner and outer surfaces of the cr filter and de-bubbling material found the adhesion of red thrombus on both inner surfaces.Either of the components had no anomaly or break on it.The venous filter and the de-bubbling material housed in the venous filter were taken out of the reservoir for further inspection.Visual inspection of the inner and outer surfaces of the venous filter and de-bubbling material found the adhesion of red thrombus on the outer surface of the de-bubbling material.Either of the components had no anomaly or break on it.A review of the device history record confirmed that there is no indication of production-related problems.A search of the complaint file found no other report of this nature with the involved product/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 it is likely that blood suctioned into the suction line may have been mixed with a large amount of air causing coagulation.The device labeling does address the potential for such an event in the instruction for use (ifu) with statements such as the following: (1) adequate heparinization of the blood is required to prevent it from clotting in the system; and (2) do not reduce heparin during circulation.Otherwise, blood clotting might occur.(b)(4).All available information has been placed on file in quality assurance for appropriate tracking, trending and follow-up.(b)(4).

Event Description

The user facility reported thrombus in the capiox cx-fx25rw device.Follow up communication with the user facility reported the following information: (1) an operation for avr+cabg was being conducted; (2) the procedure took about 5 hours; (3) the patient was administered with hd; (4) atc increased more than 400, but it soon decreased to lower than 300 sec.; (5) at the weaning stage after protamine was dosed, the customer lowered the solution level in the reservoir in order to collect the blood in the reservoir; (6) at this time a large mass of thrombus was noted inside of the vr; (7) the procedure was completed successfully; and (8) there was no impact to the patient.

• Brand Name: CAPIOX FX25 HOLLOW FIBER OXYGENATOR AF
• Type of Device: OXYGENTOR
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, shizuoka 418 ; JA 418
• Manufacturer (Section G): TERUMO CORPORATION, ASHITAKA; reg. no. 9681834; 150 maimaigi-cho; fujinomiya city, shizuoka 418 ; JA 418
• Manufacturer Contact: jennifer suh ; reg. no. 2243441; 2101 cottontail ln.; somerset, NJ 08873 ; 8002837866
• MDR Report Key: 5117518
• MDR Text Key: 27252971
• Report Number: 9681834-2015-00202
• 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: company representative,foreig
• Reporter Occupation: Other
• Report Date: 09/04/2015,10/01/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2018
• Device Catalogue Number: CX-FX25RW
• Device Lot Number: 150511
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2015
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 09/03/2015
• Device Age: 4 MO
• Event Location: Hospital
• Date Report to Manufacturer: 09/04/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/01/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/11/2015
• 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
• Patient Age: 80 YR