MAUDE Adverse Event Report: TERUMO CORPORATION ASHITAKA FX OXY W/HR & ART FILTER; BLOOD GAS OXYGENATOR

Model Number 1CX*FX25RE

Device Problem Disconnection (1171)

Patient Problem No Patient Involvement (2645)

Event Date 03/07/2014

Event Type  malfunction  

Event Description

The user facility reported to terumo cardiovascular systems that prior to cardiopulmonary bypass, during setup, the tubing from the oxygenator was not connected.No patient involvement as this occurred during setup.Product was not used.Surgery was completed successfully.

Manufacturer Narrative

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

• Brand Name: FX OXY W/HR & ART FILTER
• Type of Device: BLOOD GAS OXYGENATOR
• Manufacturer (Section D): TERUMO CORPORATION ASHITAKA; 150 maimaigi-cho; fujinomiya city, shizuoka prefecture 418 ; JA 418
• Manufacturer (Section G): TERUMO CORPORATION ASHITAKA
• Manufacturer Contact: eileen dorsey, manager ; 125 blue ball rd.; elkton, MD 21921 ; 8002623304
• MDR Report Key: 3813250
• MDR Text Key: 4478560
• Report Number: 9681834-2014-00090
• 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: 03/10/2014

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: 06/30/2016
• Device Model Number: 1CX*FX25RE
• Device Lot Number: 130704
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Device Age: 8 MO
• Event Location: Hospital
• Initial Date Manufacturer Received: 03/10/2014
• Initial Date FDA Received: 03/27/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/04/2013
• 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