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

Catalog Number CX*FX25RW

Device Problem Filtration Problem (2941)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/04/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The actual device has not been returned to the manufacturing facility for evaluation.For this reason, evaluation code was used in the conclusions.A follow up report will be submitted within 30 days of this report being sent.A review of the device history record and the product release decision control sheet of the involved product/lot # combination was conducted with no relevant findings.A search of the complaint file did not find any other report with the involved product code/lot# combination.(b)(4).All available information has been placed on file in quality assurance for appropriate tracking, trending and follow-up.

Event Description

The user facility reported a clot in the capiox device during a procedure.Follow up communication with the user facility confirmed the following information; the procedure was for a coronary bypass; at the end of ecc, the presence of a fresh blood clot around the ecc oxygenator reservoir filter was noted; act went from 538 seconds at the beginning of the procedure to 370 seconds at the end of the procedure; over 100 min of ecc during the procedure, without the addition of heparin; the oxygenator was not changed because the blood clot was detected at the end of procedure during the tank purging; there was no blood loss or delay in the procedure; and the patient was treated as intended.

Manufacturer Narrative

The actual device was returned to the manufacturing facility for evaluation.Visual inspection found no anomalies.The reservoir was rinsed and dried.The venous filter and the cardiotomy filter were separated from the reservoir for further visual and magnifying inspections.No anomalies were revealed.The oxygenator module was rinsed and dried and then, built into a circuit with tubes and bovine blood was circulated in it.The pressure drop was determined at each flow rate.The obtained values were verified to meet manufacturing specifications.Bovine blood was circulated in the actual sample for 6 hours.There was no generation of obstruction in the device.After the circulation test, the actual sample was flushed with saline solution.Subsequent visual inspection of the actual sample confirmed that there was no clot formation.Information provided by the user facility confirmed that the procedure lasted over an hour and a half.During this time heparin was not added to the device.There is no evidence that this event was related to a device defect or malfunction.The investigation result verified that the actual sample was the normal product.Although the exact cause of the reported event cannot be definitively determined it is likely that due to no addition of heparin during the procedure the blood containing activated coagulation factors stagnated on the fluid surface leading to the clot formation.The device labeling does address the potential for such an event in the instruction for use (ifu) with statements such as the following: do not reduce heparin during circulation.Otherwise, blood clotting might occur; and adequate heparinization of the blood is required to prevent it from clotting in the system.All available information has been placed on file in quality assurance for appropriate tracking, trending and follow-up.

• Brand Name: CAPIOX FX OXYGENATOR
• Type of Device: OXYGENATOR
• 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: 6340014
• MDR Text Key: 67927936
• Report Number: 9681834-2017-00014
• Device Sequence Number: 1
• Product Code: DTZ
• UDI-Device Identifier: 04987350701046
• UDI-Public: 04987350701046
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K071494
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/17/2017

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: 04/30/2019
• Device Catalogue Number: CX*FX25RW
• Device Lot Number: 160513
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/18/2017
• Initial Date FDA Received: 02/17/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/28/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/13/2016
• 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 Age: 70 YR
• Patient Weight: 70