MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORP. STERILE FX25RW OX W/RES ; BLOOD GAS OXYGENATOR

Model Number 3CX*FX25RW

Device Problem Coagulation in Device or Device Ingredient (1096)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/10/2015

Event Type  malfunction  

Event Description

The user facility reported to terumo cardiovascular systems corporation that fibrin was present at the front of the venous reservoir after sixty (60) minutes of cec.After cardiopulmonary bypass, the oxygenator was visually inspected and a few, small white/red clots were found on the post-filter portion of the oxygenator.The device was not changed out, and the procedure was completed successfully without delay.No known impact or consequence to pt.Product was not changed out.Surgery was completed successfully without delay.

Manufacturer Narrative

Terumo has not received the actual device for eval; therefore, the investigation has yet to be completed.Terumo plans on submitting a follow-up report when the investigation is complete and more info becomes available.For this reason, terumo referenced eval conclusion code.(b)(4).

Manufacturer Narrative

The actual sample was visually inspected upon receipt, during which it was noted that there was blood saturation within the filter of the reservoir and within the oxygenator, but no clotting was visible.The returned sample was then sent to an outside lab, avomeen analytical services for identification of the biological material within the device.During the outside facility's investigation a layer of residue was found and carefully scraped from the walls of the reservoir and collected for ft-ir analysis.The spectrum of residue exhibited a characteristic set comparable to a common silicone lubricant.There was also prominence of urea in the blood.It was verified that the x-coating from within the reservoir was not a significant interference in the residue.The scraped residue was also analyzed by edxa to confirm the presence of silicon in the residue.Edxa is an analytical technique used for the elemental analysis or chemical characterization of a sample.Two separate scrapings of residue were tested, each containing about 14% silicon.A review of the device history record revealed no anomalies.A definitive root cause as to how these materials were introduced into the device and blood could not be determined.All available information has been placed on file in quality management for appropriate tracking, trending and follow up.

• Brand Name: STERILE FX25RW OX W/RES
• Type of Device: BLOOD GAS OXYGENATOR
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORP.; 125 blue ball rd.; elkton MD 21921
• Manufacturer (Section G): TERUMO CARDIOVASCULAR SYSTEMS CORP.; 125 blue ball rd.; elkton MD 21921
• Manufacturer Contact: robyn o'donnell, qlty mgr ; 125 blue ball rd.; elkton, MD 21921 ; 8002623304
• MDR Report Key: 4931027
• MDR Text Key: 6049344
• Report Number: 1124841-2015-00212
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140774
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative,Distributor,company rep
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/13/2016

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: Health Professional
• Device Expiration Date: 02/28/2018
• Device Model Number: 3CX*FX25RW
• Device Lot Number: TD30
• Other Device ID Number: (01) 00699753450479
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2015
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Device Age: 4 MO
• Event Location: Hospital
• Initial Date Manufacturer Received: 07/13/2015
• Initial Date FDA Received: 07/20/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/13/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/30/2015
• 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