MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORP. STERILE FX25RWC W/ RES; BLOOD GAS OXYGENATOR

Model Number 3CX*FX25RWC

Device Problem Use of Device Problem (1670)

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

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer reported to terumo cardiovascular that after cardiopulmonary bypass, there was a white clot in the oxygenator.Procedure was completed successfully.No known impact or consequence to patient.

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 december 15, 2016.A second follow-up will be submitted upon completion of the investigation and/or submission of new information, thus tcvs references conclusion code.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 ¿ and as indicated by terumo cardiovascular systems in the initial report submitted.(b)(4).The oxygenator sample and reservoir were returned with two containers filled with biological samples.The bottles were sent to an outside lab.Pathology testing was performed on the biological samples.The analysis resulted in unidentified foreign debris present within the clotted blood sample.The character of the foreign material present is not specific for a specific substance and the material was not able to be identified by light microscopy.Key features of the material include areas of fibrillar to filamentous material.The oxygenator sample was returned to (b)(4) for evaluation.The sample was built into a circuit where bovine blood was circulated and the pressure drop was determined at each flow rate.The obtained values met all specifications and no clots were found.The bovine blood was then circulated for 6 hours, no clots were found.The bovine blood was then rinsed and visually inspected, no clots were found in the device.A review of the device history record revealed no manufacturing anomalies.The reported event was not able to be replicated; therefore, a definitive root cause was not able to be determined and this complaint is not confirmed.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.

• Brand Name: STERILE FX25RWC W/ RES
• Type of Device: BLOOD GAS OXYGENATOR
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORP.; 125 blue ball road; elkton MD 21921
• Manufacturer Contact: cathleen hargreaves ; 125 blue ball road; elkton, MD 21921 ; 8002837866
• MDR Report Key: 6178724
• MDR Text Key: 62532930
• Report Number: 1124841-2016-00429
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151791
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2019
• Device Model Number: 3CX*FX25RWC
• Device Catalogue Number: N/A
• Device Lot Number: UK29
• Other Device ID Number: (01)00699753450837
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/31/2016
• 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