MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION 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 09/09/2015

Event Type  malfunction  

Manufacturer Narrative

Terumo has not received the actual device for evaluation; therefore, the investigation has yet to be completed.A follow-up report will be submitted when the investigation is complete and/or more information becomes available.(b)(4).All available information has been placed on file in quality management for appropriate tracking, trending and follow up.

Event Description

The user facility reported to terumo cardiovascular systems corporation that after cpb, when the oxygenator was rinsed with clear liquid, a deposition of organic-like material was observed in the post-filter of the oxygenator space.The user facility further stated that their anticoagulation protocol was strictly followed.No known impact or consequence to patient.Device was not changed out as the event occurred after the completion of cpb.Procedure completed successfully without delay.

Manufacturer Narrative

This follow-up report is submitted to fda in accord with applicable regulations and as indicated by terumo cardiovascular system in the initial report submitted to the fda on october 8, 2015.(b)(4).All available information has been placed on file in quality management for appropriate tracking, trending and follow up.

Manufacturer Narrative

This follow-up report is submitted to the fda in accord with applicable regulations - and as indicated by terumo cardiovascular system.Upon further investigation of the reported event, the following information is new and/or changed: (date received by manufacturer).(indication that this is a second follow-up report).(follow-up due to device evaluation).(device evaluated by manufacturer).(b)(4).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 CORPORATION; 125 blue ball road; elkton MD 21921
• Manufacturer Contact: robyn o'donnell ; 125 blue ball road; elkton, MD 21921 ; 8002623304
• MDR Report Key: 5136678
• MDR Text Key: 28095703
• Report Number: 1124841-2015-00267
• 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: company representative,distri
• Reporter Occupation: Other
• Type of Report: Followup,Followup
• Report Date: 01/12/2016

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: Other
• Device Expiration Date: 04/30/2018
• Device Model Number: 3CX*FX25RW
• Device Lot Number: TF19
• Other Device ID Number: (01)00699753450479
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/08/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 11/02/2015; 01/12/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/18/2015
• 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