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

Model Number ICX*FX05RE

Device Problem Device Damaged Prior to Use (2284)

Patient Problem No Patient Involvement (2645)

Event Date 02/24/2014

Event Type  malfunction  

Event Description

The user facility reported to terumo cardiovascular systems that prior to cardiopulmonary bypass, during set up, the venous temperature port on top of the reservoir of the oxygenator was broken.No pt involvement as this occurred during set up.Product was not used.Surgery was completed successfully.

Manufacturer Narrative

Terumo has received the actual device for evaluation; however, the investigation has yet to be completed.Terumo plans on submitting a f/u report when the investigation is complete and more info becomes available.(b)(4).

• Brand Name: BABY FX OXY W/HR & ART FILTER
• Type of Device: BLOOD GAS OXYGENATOR
• Manufacturer (Section D): TERUMO CORP, ASHITAKA; 150 maimaigi-cho; fujinomiya city, shizuoka,prefecture 418 ; JA
• Manufacturer (Section G): TERUMO CORP., ASHITAKA; 150 maimaigi-cho; fujinomiya, shizuoka ; JA
• Manufacturer Contact: eileen dorsey, mgr. ; 125 blue ball rd; elkton, MD 21921 ; 8002623304
• MDR Report Key: 3830015
• MDR Text Key: 16549456
• Report Number: 9681834-2014-00074
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K071572
• 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: 02/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 04/30/2016
• Device Model Number: ICX*FX05RE
• Device Lot Number: 130531
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/04/2014
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Device Age: 9 MO
• Event Location: Hospital
• Date Manufacturer Received: 02/24/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/28/2013
• 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