MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION NS FX25RWC W/RES; BLOOD GAS OXYGENATOR

Model Number 3ZZ*FX25RWCA

Device Problem Temperature Problem (3022)

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

Event Date 10/10/2016

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.For this reason, (b)(4).

Event Description

The user facility reported to terumo cardiovascular that prior to cardiopulmonary bypass, during prime, the venous prime fluid temperature is reading higher than the arterial outlet temperature by about 1 degree c.No known impact or consequence to patient.Product was not 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 october 28, 2016.A second follow-up will be submitted upon completion of the investigation and/or submission of new information.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.

Manufacturer Narrative

The sample was returned for evaluation.A review of the device history record revealed no manufacturing anomalies.The returned sample consisted of only the oxygenator, with the arterial thermistor.Visual inspection of the returned sample found no anomalies, specifically around the thermistor.The unit was setup in a circuit and water was circulated through the unit.The temperature of the water from the water supply was measured as well as the temperature of the fluid at the oxygenator's thermistor.The temperatures of the fluid at both locations matched exactly.The reported event was not able to be replicated and the complaint was not confirmed.If temperatures are taken at two separate locations and then compared, the variability in the fluid may cause the temperatures to truly be different at these different locations.The temperature at the venous thermistor is likely to vary from the temperature at the arterial thermistor, especially due to the fluid going through the heat exchanger between these two locations.If temperatures are read at a time that the fluid is being warmed or cooled, and a steady state temperature is not achieved prior to measuring this temperature, this will also cause a difference in readings.All available information has been placed on file in quality management for appropriate tracking, trending and follow up.

• Brand Name: NS FX25RWC W/RES
• Type of Device: BLOOD GAS OXYGENATOR
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; 125 blue ball rd; elkton MD 21921
• Manufacturer Contact: cathleen hargreaves ; 125 blue ball rd; elkton, MD 21921 ; 8002837866
• MDR Report Key: 6063460
• MDR Text Key: 58662711
• Report Number: 1124841-2016-00367
• 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: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2016
• 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: 3ZZ*FX25RWCA
• Device Catalogue Number: N/A
• Device Lot Number: UK01
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/19/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/02/2016
• 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