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

Catalog Number CX-XRX55801

Device Problem Occlusion Within Device (1423)

Patient Problem Blood Loss (2597)

Event Date 08/26/2016

Event Type  Injury  

Manufacturer Narrative

The actual device was discarded by the involved facility.Therefore, the investigation was based on the evaluation of the user facility information and a retention sample from the same manufacturing date as the reported device.Visual inspection revealed no anomalies in the appearance.Bovine blood was circulated in the sample, while the pressure loss at the cr filter housed inside the reservoir was determined.The obtained values were confirmed to meet manufacturing specifications.No anomalies which could lead to clot formation were noted.Bovine blood was circulated in the sample for 6 hours.During this circulation, no obstruction occurred in the circulation and there were no visible clot formation found inside.The cr filter was disassembled and rinsed with saline solution.Subsequent visual inspection of the cr filter and defoamer set inside the cr filter found no clot formation on those components.The cr filter and defoamer were rinsed with hypochlorous acid solution so as to remove the blood cell components adhering on them.Subsequent electron microscopic inspection of those components did not reveal any anomalies which could lead blood to clot.A review of the device history record and the product release decision control sheet of the involved product code/lot # combination was conducted with no relevant findings.A search of the complaint file found no other report with the involved product code/lot# combination.There is no evidence that this event was related to a device defect or malfunction.The investigation result verified that the retention sample had no anomalies which could lead to the reported clotting.Although the exact cause of the reported event cannot be definitively determined based on the available information, many clinical variables could have lead to the reported issue.The device labeling does address the potential for such an event in the instructions-for-use (ifu) with statements such as the following: "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." (b)(4).All available information has been placed on file in quality assurance at the manufacturing facility for appropriate tracking, trending and follow-up.Actual device was discarded.

Event Description

The user facility reported formation of clots during the use of the capiox device.Follow up communication with the user facility confirmed the following information: the customer noticed that clots had formed on the cr filter housed in the hard shell reservoir; to prevent the clots from flowing into the oxygenator module side, the customer changed out the reservoir and oxygenator module to new ones; the amount of bloodloss is unknown; the procedure was completed successfully; and the patient recovered.

• Brand Name: CAPIOX FX OXYGENATOR
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• 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: 5971345
• MDR Text Key: 55422640
• Report Number: 9681834-2016-00226
• 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
• Type of Report: Initial
• Report Date: 09/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2017
• Device Catalogue Number: CX-XRX55801
• Device Lot Number: 160524
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/26/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/24/2016
• 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 Outcome(s): Other