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

Catalog Number CX-FX25RE

Device Problem Increase in Pressure (1491)

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

Event Date 04/03/2017

Event Type  malfunction  

Manufacturer Narrative

Udi number not required for this product code.The actual device was returned to the manufacturing facility for evaluation.Visual inspection found no obvious anomalies.The device was rinsed with saline solution and visually inspection again with the unaided eye.No clot formation was noted.Based on the provided information, the pressure drop had been kept high from the priming stage to the end of the procedure, the actual device and a current product sample were determined for the pressure drop.There was no difference in the result between the actual device and the current product sample.The pump record revealed there was no use of blood-derived component in the initial filling solution.A review of the device history record and 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.Visual inspection found no clots and the actual device did not have any obstruction which could have led to a rise in the pressure drop.The exact cause of the reported event cannot be definitively determined.(b)(4).All available information has been placed on file in quality assurance at the manufacturing facility for appropriate tracking, trending and follow-up.

Event Description

The user facility reported pressure increase in the capiox device during a procedure.Follow up communication with the user facility reported the pressure drop was kept high from the priming stage to the end of the procedure.

• 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: 6529175
• MDR Text Key: 74152145
• Report Number: 9681834-2017-00081
• 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: 04/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2019
• Device Catalogue Number: CX-FX25RE
• Device Lot Number: 161208
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/03/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/08/2016
• 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
• Treatment: DLP SINGLE STAGE VENOUS CANNULAE 22FR. (66122); TOYOBO CANNULAE 20FR. PCKC-A-20; TOYOBO CANNULAE 20FR. PCKC-V-24
• Patient Outcome(s): Required Intervention
• Patient Weight: 90