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

Model Number 1CX*FX25RE

Device Problem Device Damaged Prior to Use (2284)

Patient Problems No Patient Involvement (2645); Insufficient Information (4580)

Event Date 03/28/2014

Event Type  malfunction  

Event Description

The user facility reported to terumo cardiovascular systems that prior to cardiopulmonary bypass, during set up, the recirculation line off the arterial outlet became separated from the luer connection of the oxygenator.No pt involvement as this occurred during set up.Product was not used.Surgery was completed successfully.

Manufacturer Narrative

Terumo corp 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).

Manufacturer Narrative

Visual inspection of the device confirmed the complaint, as the sampling line tube had fractured at the edge of the female luer connector on the oxygenator module.A review of the device history record revealed no anomalies.A retention sample was tested against physical elements, and it was concluded that the actual sample was likely exposed to an instantaneous shock force after it was exposed to low temperatures during shipping and/or handling.The product undergoes a 100 percent visual inspection in the production process.All available information has been placed on file in quality management for appropriate tracking, trending and follow up.

Manufacturer Narrative

This report is being submitted as follow up # 2 to correct the date of event that was reported as (b)(6) 2014 in follow up # 1.The correct date of event is (b)(6) 2014.

• Brand Name: FX OXY W/HR & ART FILTER
• Type of Device: BLOOD GAS OXYGENATOR
• Manufacturer (Section D): TERUMO CORP, ASHITAKA; 150 maimaigi-cho; fujinomiya city, shizuoka,perfecture 418 ; JA
• Manufacturer (Section G): TERUMO CORP, ASHITAKA; 150 maimaigi-cho; fujinomiya city, shizuoka,prefecture 418 ; JA
• Manufacturer Contact: eileen dorsey, mgr ; 125 blue ball rd; elkton, MD 21921 ; 8002623304
• MDR Report Key: 3866865
• MDR Text Key: 15805391
• Report Number: 9681834-2014-00116
• 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,Distributor
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 04/01/2014

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*FX25RE
• Device Lot Number: 130805
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2014
• 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: 04/01/2014
• Initial Date FDA Received: 04/25/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/05/2013
• 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