MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION NS FX15REC W/4L RES; BLOOD GAS OXYGENATOR

Model Number 3ZZ*FX15RE40CA

Device Problem Use of Device Problem (1670)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/14/2021

Event Type  Injury  

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, there was an oxygenation issue.Cpb was initiated with a standard fx15.Shortly after initiation and applying the xc, it was noticed that the pao2 was abnormally low around 150.After calibrating the cdi with 100% fio2, the pao2 was still reading below 200.The recirculation line was opened to increase oxygenation and allow time to cut in a fx25.Once fx25 was spliced in, the pao2 became therapeutic between 200-300.As time went on, the pao2 began to trend downwards, the co2 began to increase with a higher sweep needed and the oxygen consumption began to increase as well.Oxygen delivery was always within range and potassium was always between 3.0-5.5.The baseline act was 155 at 0958.The initial dose of heparin was given at 1052.Post heparin bolus act was 845 at 1057.Cpb was initiated at 1119.Act was 650 at 1132, 584 at 1200, 461 at 1239, 539 at 1259 and 113 at 1321.An additional 5,000 units administered after act came back at 461 at 1239.The heparin levels were monitored and concentrations were between 2.2-4.0mg/kg throughout the pump run.The patient had no previous history of heparin exposure and no prior surgical interventions.The hct/hb values were as high as 37/12.3.Went on pump with a hct of 28 after rap/aap.Post protamine/products was 24/8.Final lactate after bypass at 1620 was 1.6, no lactates done during the case.Venous saturations were within the range prior to cpb.The patient was given 1 unit of rbc's.No consequence or impact 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 november 3, 2021.  upon further investigation of the reported event, the following information is new and/or changed: g6 (indication that this is a follow-up report).H2 (follow-up due to additional information).H3 (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 conclusions code 11.).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.Upon further investigation of the reported event, the following information is new and/or changed: d4 (additional device information - added expiration date).G3 (date received by manufacturer).G6 (indication that this is a follow-up report).H2 (follow-up due to additional information and device evaluation).H3 (device evaluated by manufacturer).H4 (device manufacture date).H6 (identification of evaluation codes 10, 3331, 213, 4315).Type of investigation #1: 10 - testing of actual/suspected device.Type of investigation #2: 3331 - analysis of production records.Investigation findings: 213 - no device problem found.Investigation conclusions: 4315 - cause not established.The returned sample was inspected upon receipt to show no visual anomalies with the device.After rinsing and drying the sample, the sample was built into a circuit with bovine blood and tested for gas transfer performance at applicable flow levels.The affected sample met factory specifications for oxygen transfer and carbon dioxide removal.The event could not be replicated in laboratory conditions, it is not possible to determine a true root cause of this event.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.

• Brand Name: NS FX15REC 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: 12743985
• MDR Text Key: 279808933
• Report Number: 1124841-2021-00250
• 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 Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2024
• Device Model Number: 3ZZ*FX15RE40CA
• Device Catalogue Number: N/A
• Device Lot Number: ZD15
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/20/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/15/2021
• 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): Required Intervention
• Patient Age: 32 YR
• Patient Race: White