MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA CAPIOX FX25; OXYGENATOR

Catalog Number CX-XRX32502

Device Problem Complete Blockage (1094)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/03/2016

Event Type  malfunction  

Manufacturer Narrative

The involved device has not been returned to the user facility for evaluation and the production lot number is not known.Therefore, a meaningful evaluation of retention samples, device history records and complaint files could not be conducted.A review of the involved pump record did not find an increase in the pressure drop during the procedure or any factor which would have contributed to the thrombus formation.The customer reported a similar event for the capiox device.See mdr number 9681834-2016-00037 for details.There is no evidence that this event was related to a device defect or malfunction and a definitive cause of this complaint cannot be 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.Actual device not returned.

Event Description

The user facility reported a clog in the capiox device.Follow up communication with the user facility confirmed the following information: (1) in a tta case, before the weaning, the pressure inside of the reservoir became positive and saline solution came out of the quick priming port; (2) bioglue and beriplast were used; (3) the procedure was completed successfully; and (4) the patient was not harmed.

• Brand Name: CAPIOX FX25
• 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: 5488434
• MDR Text Key: 39935126
• Report Number: 9681834-2016-00036
• 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: 03/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CX-XRX32502
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/09/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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