MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA CAPIOX FX 15 HOLLOW FIBER OXYGENATOR AF; OXYGENTOR

Catalog Number 1CX*FX15E

Device Problem Coagulation in Device or Device Ingredient (1096)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/15/2015

Event Type  malfunction  

Manufacturer Narrative

The actual device has not been returned to the manufacturing facility for evaluation.A follow up 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.(b)(4).Actual device not returned.

Event Description

The user facility reported thrombus in the capiox cx fx15e device.Follow up communication with the user facility reported the following information: (1) the device clotted off during cardiopulmonary bypass; (2) it was reported protamine was given prior to coming off bypass; and (3) no known impact to the patient.

Manufacturer Narrative

This report is being submitted as follow up no.1 for mfg.Report no.9681834-2015-00266 to provide an update on the status of this report.The complaint documented that the quantity of the implicated unit was one.Two devices were received by the manufacturing facility and both were evaluated.Visual inspection did not find any obvious anomalies in the appearance.The samples were rinsed and dried.Another visual inspection did not find any obvious anomalies in the appearance.The samples were built into a circuit with tubes, where bovine blood was circulated at each flow rate to determine the pressure drop.The obtained values were confirmed to meet manufacturing specifications.Bovine blood was circulated in the circuit for 6 hours, no anomalies were noted.The bovine blood was removed from the actual samples and the oxygenator modules were subjected to another visual inspection.No presence of blood clot forming was confirmed.The actual samples, after having been rinsed and dried, were verified to be the normal product.There is no evidence that this event was related to a device defect or malfunction.The exact cause cannot be determined, based on the provided information that protamine was given prior to coming off bypass, it is conceivable that protamine activated clotting factors in the blood resulting in the reported blood clot formation.All available information has been placed on file in quality assurance at the manufacturing facility for appropriate tracking, trending and follow-up.

Event Description

This report is being submitted as follow up no.1 for mfg.Report no.9681834-2015-00266 to provide an update on the status of this report.

Manufacturer Narrative

As stated in section b5, this report is being submitted as follow up no.2 for mfg.Report no.9681834-2015-00266 to report the patient expired.

Event Description

This report is being submitted as follow up no.2 for mfg.Report no.9681834-2015-00266 to report the patient expired.

• Brand Name: CAPIOX FX 15 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: 5353458
• MDR Text Key: 35389241
• Report Number: 9681834-2015-00266
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: US
• 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,Followup
• Report Date: 12/16/2015,01/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2018
• Device Catalogue Number: 1CX*FX15E
• Device Lot Number: 150605
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2016
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 12/15/2015
• Device Age: 7 MO
• Event Location: Hospital
• Date Report to Manufacturer: 12/16/2015
• Initial Date Manufacturer Received: 12/16/2015
• Initial Date FDA Received: 01/08/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 02/03/2016; 03/17/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/05/2015
• 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 Outcome(s): Death