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

Model Number 1CX*FX25RE

Device Problem Device Damaged Prior to Use (2284)

Patient Problem No Patient Involvement (2645)

Event Date 03/04/2014

Event Type  malfunction  

Event Description

The user facility reported to terumo cardiovascular systems that out of box, the recirculation line separated from the arterial outlet, and there was a crack noted on the arterial outlet.No patient involvement as this occurred out of box.

Manufacturer Narrative

Terumo has received the actual device for evaluation; however, 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 road; elkton, MD 21921 ; 8002623304
• MDR Report Key: 3813238
• MDR Text Key: 20328670
• Report Number: 9681834-2014-00088
• 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: 03/07/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 05/31/2016
• Device Model Number: 1CX*FX25RE
• Device Lot Number: 130627
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/14/2014
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Device Age: 8 MO
• Event Location: Hospital
• Date Manufacturer Received: 03/07/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/27/2013
• 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