MAUDE Adverse Event Report: TERUMO CORP, ASHITAKA FX OXY W/HR AND ART FILTER; BLOOD GAS OXYGENATOR

Model Number 1CX*FX15RE30

Device Problem Disconnection (1171)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

The user facility reported to terumo cardiovascular systems that prior to cardiopulmonary bypass, during prime, the 1/4 x 3/8 reducer (the reducers that attach to the reservoir) leaked when attached to the reservoir outlet.No pt involvement as this occurred during prime.The product was not changed out.The surgery was completed successfully.

Manufacturer Narrative

Terumo has not received the actual device for eval; therefore, the investigation has yet to be completed.Terumo plans on submitting a follow up report when the investigation is completed and more info becomes available.(b)(4).

• Brand Name: FX OXY W/HR AND ART FILTER
• Type of Device: BLOOD GAS OXYGENATOR
• Manufacturer (Section D): TERUMO CORP, ASHITAKA; 150 maimaigi-cho; prefecture 418; fujinomiya, shizuoka ; JA
• Manufacturer (Section G): TERUMO CORP, ASHITAKA; 150
• Manufacturer Contact: eileen dorsey, pa manager ; 125 blue ball rd; elkton, MD 21921 ; 8002623304
• MDR Report Key: 3962501
• MDR Text Key: 4609535
• Report Number: 9681834-2014-00196
• 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: Not Applicable
• Type of Report: Initial
• Report Date: 06/09/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 07/31/2016
• Device Model Number: 1CX*FX15RE30
• Device Lot Number: 130819
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Date Manufacturer Received: 06/09/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/19/2013
• 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