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

Model Number 3ZZ*FX25RWCA

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Blood Loss (2597)

Event Date 07/17/2017

Event Type  Injury  

Manufacturer Narrative

Terumo has received the device for evaluation; however, 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, terumo references evaluation conclusion code.(b)(4).Results: results pending completion of evaluation.Conclusions: conclusion not yet available-evaluation in progress.

Event Description

The user facility reported to terumo cardiovascular that during cardiopulmonary bypass, the oxygenator failed.The user facility reported to terumo cardiovascular systems corporation that during cardiopulmonary bypass, the oxygenator failed.When the perfusionist first went on bypass to complete a cabg x 2, the venous saturation was ~78% and then dropped to ~68% after approximately one minute.It was noticed that the blood exiting the oxygenator was dark, and not a bright red color.The gas line connection to the oxygenator was checked and confirmed to have air flow through the line.A line from an oxygen tank was then connected directly to the oxygenator at ~8 lpm, and the blood color became slightly brighter, but not substantially.The perfusionist then filled the heart with the blood from the reservoir and went off bypass.The patient was stable and able to support their own cardiac output.The perfusionist moved the oxygen line from the electronic blender to a standalone blender and went back on bypass; still the blood was not a bright red.The gas out port for air was examined, and not a lot of air was felt exiting the device.It was then decided that the entire circuit would be changed out rather than just the oxygenator as the patient was stable and able to support herself.The change out took approximately 10 minutes.Bypass was initiated on the new circuit and immediately it was noticed that the arterial blood was turning bright red.The venous oxygen saturation % was rising and in the appropriate range for bypass.Surgery was completed successfully without any further issues.No known harm to the patient.Product was changed out.Blood loss amount of 250ml.Delay for 10 minutes.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 august 7, 2017.(b)(4).Visual inspection of the received sample did not find any anomaly, such as break in the appearance.The sample was tested for its gas transfer performance in accordance to the factory's shipping inspections protocol.No anomalies were revealed in the gas transfer performance of the actual sample, with the obtained values meeting the factory specifications.A definitive root cause could not be determined; therefore, 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: NS FX25RWC W/RES
• Type of Device: BLOOD GAS OXYGENATOR
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; 125 blue ball road; elkton MD 21921
• Manufacturer Contact: cathleen hargreaves ; 125 blue ball road; elkton, MD 21921 ; 8002837866
• MDR Report Key: 6772055
• MDR Text Key: 82006627
• Report Number: 1124841-2017-00167
• 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: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2020
• Device Model Number: 3ZZ*FX25RWCA
• Device Catalogue Number: N/A
• Device Lot Number: VC27
• Other Device ID Number: (01)00699753450820
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/22/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/28/2017
• 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
• Patient Outcome(s): Other