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

Model Number 3CX*FX15RE40C

Device Problem Use of Device Problem (1670)

Patient Problems Renal Failure (2041); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/06/2023

Event Type  malfunction  

Event Description

The user facility reported to terumo cardiovascular that during cardiopulmonary bypass, the oxygenator had an over pressurization.The procedure was an nrp procedure, the patient is pronounced dead before the perfusionist goes on bypass; the patient died of cerebral stroke.The patient had an ongoing bypass to oxygenate and preserve the kidneys for organ harvest.The perfusionist went on bypass and immediately had decreasing line pressure and flows but increasing rpms constantly.This continued until he was unable to flow at all after 34 minutes and had to come off bypass and terminate the procedure.There was not enough forward flow to even circulate through the recirc line after he was off bypass and had sucked the circuit (and oxy) dry (of blood) and replaced with 2 liters crystalloid to try and circulate.There was no clot or fibrin strands seen anywhere in fx15 (even at the surgical field).Patient was normothermic.Femoral cannulation 19f return artery and 25f vein cannulas.At 22:55, anesthesia gave 30, 000 heparin before extubating.10,000 heparin in perfusion prime as well as 2l normosol, 10mg decuronium, 100meq nahco3, 2g magnesium sulfate, 1g 10% calcium, 400mg ciprofloxacin, 2g cefazolin.At 22:59, they withdrew care from the patient, had agonal breath at 2300 and died at 23:12.On bypass at 23:15 and had a beginning flow of 4 lpm / line pressure, 23:17 flow 3.6lpm/pressure 134, 23:25 flow 3.2lpm/pressure 108, at 23:49 the oxygenator was unable to flow - had to off bypass.They were unable to complete the procedure because they could not flow through the oxygenator.There was no other time to harvest the organs viably, so the procedure was not completed, and they did not harvest the organs.The procedure was not able to be completed so the delay is indefinite.The organs expired.The status of the patient that would have received the kidney donation is unknown.The product was not changed out *the surgery was not completed successfully he patient had expired prior to initiating use of the oxygenator.

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, terumo references evaluation conclusion code 11.H6: component code: 4739 - gas exchanger health effect - impact code: 4633 - surgical procedure delayed health effect - clinical code: 2041 - renal failure medical device problem code: 1670 - use of device problem investigation findings: 3233 - results pending completion of investigation investigation conclusions: 11 - conclusion not yet available.

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 july 3, 2023.Upon further investigation of the reported event, the following information is new and/or changed: 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.

Event Description

Over pressurization.

Event Description

There was no serious injury or patient effect as the event occurred after the patient was deceased in order to preserve and harvest the kidneys.Additional information from the clinical specialist states, the perfusionist reported that the rpms during the case were continuously increasing on the centrifugal pump as the flows decreased, and 2 liters of crystalloid had to be added to the oxygenator/reservoir in attempt to maintain forward arterial flow.No clots or fibrin strands were evident in the fx15 oxygenator or at the surgical field at the time of termination of cpb.

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: h6 (identification of evaluation codes 4582, 10, 3331, 213, 67).Health effect ¿ clinical code: 4582- no clinical signs, symptoms or conditions.Type of investigation #1: 10 - testing of actual/suspected device.Type of investigation #2: 3331 - analysis of production records.Investigation finding: 213 - no device problem found.Investigation conclusions: 67 - no problem detected.The actual sample was visually inspected and found that there was no anomaly such as breakage.After the sample was rinsed, it was tested for the pressure drop with bovine blood with a maximum flow rate obtained at 5 liters per minute.The pressure drop was within the factory's specification.No clogging was observed.The blood channel was rinsed with normal saline with no formation of blood clot.There were no anomalies found during evaluation, and it was not possible to clarify the cause of the complaint from the investigation result.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.

• Brand Name: STERILE 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: douglas patton ; 125 blue ball road; elkton, MD 21921 ; 7346634145
• MDR Report Key: 17248741
• MDR Text Key: 318388554
• Report Number: 1124841-2023-00162
• Device Sequence Number: 1
• Product Code: DTZ
• UDI-Device Identifier: 00699753450813
• UDI-Public: (01)00699753450813
• 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: 09/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3CX*FX15RE40C
• Device Catalogue Number: N/A
• Device Lot Number: 3A23
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/25/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/24/2023
• 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
• Patient Age: 46 YR
• Patient Sex: Male