MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION STERILE FX15RWC W/ 4L RES; BLOOD GAS OXYGENATOR

Model Number 3CX*FX15RW40C

Device Problem Infusion or Flow Problem (2964)

Patient Problems Death (1802); No Consequences Or Impact To Patient (2199)

Event Date 08/27/2020

Event Type  Death  

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 during cardiopulmonary bypass, they noticed drop of oxygenation.Per user facility the patients came in with severe respiratory infection.His lvad malfunctioned and it seemed blocked so they replaced it with another.They went on bypass at 14.21 h.Oxygenation drop at 14.57 pm co2 41 /po2 78 change out oxygenator at 14.58pm at full flow 257 po2.Finished case at 16.07 pm pco2 =21, po2=251 see connect file for all data.No consequences or impact to patient.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 september 16, 2020.Upon further investigation of the reported event, the following information is new and/or changed: describe event or problem - added new information).(device availability - added date returned to manufacturer).(date received by manufacturer).(indication that this is a follow-up report).(type of reportable event - added new information).(follow-up due to additional information).(device evaluation anticipated by manufacturer - a second follow-up will be submitted upon completion of the investigation and/or submission of new information, thus tcvs references.) (event problem and evaluation codes - patient code).All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.

Event Description

New information was received indicating that on (b)(6) 2020 the patient passed away from septic shock.

Manufacturer Narrative

This follow-up report is submitted to fda in accord with applicable regulations.Upon further investigation of the reported event, the following information is new and/or changed: (additional device information - added expiration date).(date received by manufacturer).(indication that this is a follow-up report).(follow-up due to additional information and device evaluation).(device evaluated by manufacturer).(device manufacture date).Visual inspection of the sample found no obvious anomaly that could lead to poor gas transfer performance.After having been rinsed and dried, it was tested for its gas transfer performance and found no anomalies and meet the factory specification.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.

• Brand Name: STERILE FX15RWC W/ 4L RES
• Type of Device: BLOOD GAS OXYGENATOR
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; 125 blue ball road; elkton MD 21921
• Manufacturer (Section G): SAME
• Manufacturer Contact: jamie quinlan ; 125 blue ball road; elkton, MD 21921 ; 8002837866
• MDR Report Key: 10541773
• MDR Text Key: 207187890
• Report Number: 1124841-2020-00223
• Device Sequence Number: 1
• Product Code: DTZ
• UDI-Device Identifier: 00699753450790
• UDI-Public: (01)00699753450790
• 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,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 11/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2022
• Device Model Number: 3CX*FX15RW40C
• Device Catalogue Number: N/A
• Device Lot Number: XK12
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2020
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/30/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/12/2019
• 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 Age: 15 YR
• Patient Weight: 60