MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION N/S ARTERIAL FILTER XC (TOTED); ARTERIAL BLOOD FILTER

Model Number 3ZZAF200XA

Device Problem Particulates (1451)

Patient Problem No Patient Involvement (2645)

Event Date 01/17/2018

Event Type  malfunction  

Manufacturer Narrative

Terumo has not received the device for evaluation; therefore, the investigation has yet to be completed.Terumo plans on submitting a follow-up report when the investigation is complete and when more information becomes available.(b)(4).

Event Description

The user facility reported to terumo cardiovascular that prior to cardiopulmonary bypass, during prime, there is a particulate in the fiber bundle.No patient involvement.Product was changed out.Procedure was completed successfully.

Manufacturer Narrative

This follow-up report is submitted to fda in accord with applicable regulations ¿ and as indicated by terumo cardiovascular systems in the initial report submitted to the fda on january 17, 2018.(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 fda in accord with applicable regulations.(b)(4).The returned sample was visually inspected upon receipt, it confirmed the reported observation.The returned unit was cut open and the particulate/ foreign matter was carefully taken out.It was then placed on the ftir instrument and substance spectrum was obtained.The output closely match to polyaniline (pani).It was determined that the substance is not native to the tcvs facility and the supplier was notified about the issue.A retention sample was obtained from same product code / lot number, no anomalies noted including any foreign matter.All ports of the arterial filters are capped to keep the contaminants out.The actual root cause of the particulate found within the arterial filter can not be determined.It is likely that the foreign matter may have transferred to the product during handling or contaminated prime solution being used; however, it was not able to be confirmed.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.

• Brand Name: N/S ARTERIAL FILTER XC (TOTED)
• Type of Device: ARTERIAL BLOOD FILTER
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; 125 blue ball road; elkton MD 21921
• MDR Report Key: 7238665
• MDR Text Key: 99094980
• Report Number: 1124841-2018-00017
• Device Sequence Number: 1
• Product Code: DTM
• Combination Product (y/n): N
• PMA/PMN Number: K002026
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 03/23/2018

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: 04/30/2020
• Device Model Number: 3ZZAF200XA
• Device Catalogue Number: N/A
• Device Lot Number: VF29
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2018
• Initial Date Manufacturer Received: 01/17/2018
• Initial Date FDA Received: 02/02/2018
• Supplement Dates Manufacturer Received: 01/29/2018; 03/22/2018
• Supplement Dates FDA Received: 02/16/2018; 03/23/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1