MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA FX OXY W/O RESERVOIR; BLOOD GAS OXYGENATOR

Model Number 1CX FX25W

Device Problem Device Damaged Prior to Use (2284)

Patient Problem No Patient Involvement (2645)

Event Date 12/01/2012

Event Type  malfunction  

Event Description

Voluntary medwatch rec'd by (b)(4) on (b)(4) 2014.The medwatch made reference to an event that occured "1 1/2 years ago".The device was discarded.No patient involvement as this occurred during prime.Product was changed out.Surgery was completed successfully.The voluntary medwatch pertains to two other medical device reports previously submitted, and for which follow-ups shall be submitted in response: 9681834-2013-00154 and 9681834-2014-00137.(b)(4).

Manufacturer Narrative

Terumo has not rec'd the actual device for evaluation; therefore, the investigation has yet to be completed.Terumo plans on submitting a f/u report when the investigation is completed and more info becomes available.(b)(4).

• Brand Name: FX OXY W/O RESERVOIR
• Type of Device: BLOOD GAS OXYGENATOR
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya, shizuoka, prefecture 418 ; JA
• Manufacturer (Section G): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya, shizuoka ; JA
• Manufacturer Contact: eileen dorsey, ra manager ; 125 blue ball road; elkton, MD 21921 ; 8002623304
• MDR Report Key: 3952476
• MDR Text Key: 4642518
• Report Number: 9681834-2014-00169
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130520
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 05/13/2014

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 Model Number: 1CX FX25W
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/07/2014
• Event Location: Hospital
• Initial Date Manufacturer Received: 05/13/2014
• Initial Date FDA Received: 06/05/2014
• 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