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

Model Number 1CX*FX25RW

Device Problem Device Damaged Prior to Use (2284)

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 setup, the red and blue stopcocks were not bonded to the manifold tray.No pt involvement as this occurred during setup.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 f/u report when the investigation is completed and more info 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 pref 418 ; JA
• Manufacturer (Section G): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya, shizuoka ; JA
• Manufacturer Contact: eileen dorsey, mgr ; 125 blue ball road; elkton, MD 21921
• MDR Report Key: 3871722
• MDR Text Key: 17615243
• Report Number: 9681834-2014-00112
• 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: 03/27/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 1CX*FX25RW
• 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: 03/27/2014
• 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