MAUDE Adverse Event Report: TERUMO CORP. 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 Date 03/11/2014

Event Type  malfunction  

Event Description

The user facility reported to terumo cardiovascular systems that prior to cardiopulmonary bypass, during prime, the plastic adaptor that connects to the venous outlet (the reducers that attach ti the reservoir) leaked.The user rigged the connection by adding a piece of smaller tubing to stop the leak; therefore, the product was not changed out.No pt involvement as this occurred during prime.The product was not changed out.The surgery was completed successfully.

Manufacturer Narrative

Terumo has not yet 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.; blood gas oxygenator; prefecture 418; fujinomiya city, shizuoka ; JA
• Manufacturer (Section G): TERUMO CORP.; ashitaka, 150
• Manufacturer Contact: eileen dorsey, ra manager ; 125 blue ball rd; elkton, MD 21921 ; 8002623304
• MDR Report Key: 3817632
• MDR Text Key: 17996122
• Report Number: 9681834-2014-00093
• 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: 03/12/2014

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: 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
• Device Age: 7 MO
• Event Location: Hospital
• Initial Date Manufacturer Received: 03/12/2014
• Initial Date FDA Received: 03/31/2014
• 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