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

Catalog Number CX-FX25RE

Device Problem Insufficient Flow or Under Infusion (2182)

Patient Problem Death (1802)

Event Date 07/11/2016

Event Type  Death  

Manufacturer Narrative

Udi no.- not required for this product.(b)(4).The actual device was discarded by the user facility.Therefore, the investigation was limited to assessment of the user facility information, photos of the actual device and the retention sample from the involved product code/lot# combination.Review of the photos found a fluid containing blood components inside the gas in-port side.The retention sample was subjected to visual inspection.No anomalies were confirmed.The retention sample was filled with saline solution and leak tested.No leak was confirmed.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.A review of the pump record from the involved procedure did not contain any information which could lead to the reported phenomenon.Based upon the available information, the cause for the reported event cannot be definitively determined.There are many complex clinical variables that may have affected the reported observed conditions.However, there is no indication that the reported event was related to a product malfunction or defect.(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 discarded.

Event Description

The user facility reported a death during the use of a capiox device.Follow up communication with the user facility confirmed the following information: it was an aortic dissection case; the device did not pose any issue during the initial circulation; on the stage of re-circulation the gas transfer performance started to become degraded; the control was difficult with an application of 100% o2 sweep gas at 5l/min; fluid was noted to be pooled inside the outer housing of the oxygenator module; the procedure was finished without change-out of the device in question; and the patient ultimately expired.

• 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: 5871316
• MDR Text Key: 51934772
• Report Number: 9681834-2016-00188
• 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: 08/12/2016

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: 01/31/2019
• Device Catalogue Number: CX-FX25RE
• Device Lot Number: 160211
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/13/2016
• Initial Date FDA Received: 08/12/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/11/2016
• 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: TRIPLEX
• Patient Outcome(s): Death
• Patient Age: 72 YR
• Patient Weight: 70