MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION CAPIOX RX25 OXYGENATOR EAST; BLOOD GAS OXYGENATOR

Model Number 3CX*RX25RE

Device Problem Use of Device Problem (1670)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 02/21/2023

Event Type  Injury  

Event Description

The user facility reported to terumo cardiovascular that during cardiopulmonary bypass, a po2 of 155 at 16:26pm, 13 minutes later po2 was 57.As per the user facility, the perfusionist was pumping a thoracal abdominal aneurysm and cdi550 was indicating a po2 of 155 at 16:26pm, 13 mins later po2 was 57.Changed sweep and was taking co2 off just fine.Circ arrest to 18 degrees, the perfusionist changed out the oxygenator.Gave 2 units of blood, then 5 units after changed out.The patient went to ecmo.There was a 3 minute delay.There was a blood loss of 260 ml.Product was changed out.Procedure completed successfully.

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.Component code: 4739 - gas exchanger.Health effect - impact code #1: 4614 - serious injury/ illness/ impairment.Health effect - impact code #2: 4643 - blood transfusion.Heatlh effect - clinical code: 1888 - hemorrhage/bleeding.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 march 14, 2023.Upon further investigation of the reported event, the following information is new and/or changed: h6 (identification of evaluation codes 10, 3331, 213, 67).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: 67 - no problem detected the returned sample was inspected upon receipt to show no visual anomalies with the device.After rinsing and drying the sample, it was then tested for its oxygen transfer performance and carbon dioxide gas removal were measured according to the product inspection procedure.The affected sample met factory's specifications, with no anomaly found.The event could not be replicated in laboratory conditions; therefore, a definitive root cause could not be determined.Review of the manufacturing and the incoming inspection record of the involved product code/lot# found no anomalies.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.

Event Description

Additional information received by the clinical specialist, from the chief of perfusion states that, the cdi550 was calibrated and lab blood gas was checked through istat, and they do not follow do2s and vo2s.The patient was canulated split arterial, one to the leg, and one to the upper body; this was a type 2 thoracoabdominal aneurysm.They noticed the change in the oxygenator upon rewarming.Another indications that there were changes in the patient hemodynamics were; when she was called to help the perfusionist doing the case; as the hematocrits were low at 20, the cerebral saturations were 19 and the flow to the patient was low, 1 liter to the leg, and 2 liters to the upper body.This is dictated by the surgeon and depending on where he is on the procedure.The anticoagulation was good; act¿s above 1000 throughout the case, until they changed out the oxygenator.Then they were in the 600-700¿s.They had no issues with any other cardiac cases besides the thoracoabdominal cases, even with ascending dissections with circulatory arrest; for this is a 20-year program at the iu methodist.They also did not take any pvo2 lab measurements, and there was no difference happening during the case either with the surgeons¿ technique or with patient cannulation.A brief description of the case was provided, and states that the patient has a bsa of 2.0m2 and a height of 172 cm.This was a type 2 thoracoabdominal aneurysm for repair case.Patient cannulated, and on pump at 1132 with po2¿s in the 300-500¿s.Patient was cooled to 18 degrees celsius nasal-pharyngeal and 20 degrees by bladder.Circulatory arrest initiated and everything appeared good.Told to re-warm the patient to 30 degrees celsius at 1500.At 1550, the perfusionist was told to re-warm to full 37 degrees.At 1557, a blood gas was taken at fio2 of 80% and sweep of 3 with po2 of 335 and pco2 of 44.Soon afterwards, the perfusionist noticed that the cdi 550 was beginning to show the po2 declining.At 1615 the perfusionist increased the fio2 to 100%.At 1626 a lab was taken via the istat on fio2 100% and sweep of 4lpm.The po2 was 155 and the pco2 was 49.Svo2¿s was reading 78-80%.At 1639, another lab was taken with fio2 at 100%, sweep of 4lpm.Po2 was 57 and pco2 was 37.Hematocrit at 21%.Normally the hematocrits are kept between 23-24%.The flow to the two split arterial arms was 1 liter per minute to the leg and 2 liters per minute to the upper body.Total 3 liters per minute of flow at an index of 1.5.Temperature at this point was bladder at 28 degrees celsius and tympanic at 34 degrees celsius.During the case 2 units of banked blood (prbc)were given due to low hematocrits.1 more unit of prbc given at 1602, with no difference of hematocrits at the 1639 blood gas time.The decision was made to change out oxygenator at 1642.This incurred a 3- minute delay and an estimated blood loss of 260ml.First po2 after oxygenator change out was 477, flowing between 1.5 to 1.8 ci.Hematocrit at 20, cerebral saturations at 19.The chief of perfusion was called in and arrived at this time and noticed the low flow, low hematocrit, and low cerebral saturations.She increased the flow, added blood (5 units prbc between 1705-1820), 6 liters of plasmalyte was also given due to volume issues and could not keep the pump flow up to patient.At 1711, patient was at full flow, cerebral saturations had increased, svo2 was in the 60¿s and got better with increase hematocrit and flow.At 1718, a blood gas was completed, and patient was very acidotic with -8 base deficit, po2 of 447 at 90% fio2, and pco2 of 37 at a sweep of 3.5 lpm.Hematocrit was 23 after all the 8 units of prbc during the case were given.Came off cpb pump and patient was not doing well.Arterial o2 saturations of the patient were in the 80% range.Anesthesia and surgeon noticed the left lung was not looking good and there was a lot of blood from it.Hemodynamically the patient was stable, but they still had to go on v-a ecmo.Total pump time was 433 minutes.No xc time.The circulatory arrest time was 5 minutes.Total ischemic times for heart / carotid= 37 minutes, visceral = 118 minutes, lower body= 65 minutes.The lowest temp recorded was 15 degrees celsius, mostly kept at 18 degrees until re-warming to 30 degrees.The pump record has 2 areas for recording flow.One is for lower body which is the first column and 11 columns over is the heart/carotid area.They concluded that the first 2 were related to the patient and not the oxygenator.But they still think there was a failure of the oxygenator on the third case.They are thinking that it may be something to do with small clots in the oxygenator since they do not have a hepcon to direct them in heparin concentration on these cases.And they had lower flows during the case from 1214-1615.After oxygenator change out the flows were increased to 4.8 lpm.As per the clinical specialist, no venous blood samples were taken during the pump run.Venous blood samples are an good indication of the oxygenation occurring in the patient at the tissue level, versus the oxygenation level existing the arterial port of the oxygenator.A point to consider is the anesthesia level of the patient during this time.No anesthesia records were provided to indicate that the patient was sufficiently anesthetized to minimize oxygen demand and metabolism.The atypical cannulation of this patient with a split arterial line perfusing upper body and lower body of the patient may have caused a harlequin syndrome effect.Lower body blood flow at low pump values may have had suboptimum oxygenated blood being returned to the oxygenator resulting in lower-than-expected po2 values.Again, the venous saturations on the patient side were above expected values.An act device was used to measure acts and monitor anticoagulation levels and management with heparin.It is not clear if the device was calibrated prior bypass.No hepcon device, that measures heparin blood concentrations levels was employed.The acts on the failed oxygenator were all above 1000 seconds per the perfusionist.An acceptable act value for bypass is above 480seconds.From 12:00pm until 4:20pm, heparin and albumin was administered to the patient as per pump record.It is interesting to note that from the phone interview, the staff involved in this case admitted they saw small clots on the complaint oxygenator and their comment that the use of a hepcon device that measures heparin blood concentration levels would have been beneficial.

• Brand Name: CAPIOX RX25 OXYGENATOR EAST
• 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: 16537190
• MDR Text Key: 311225168
• Report Number: 1124841-2023-00065
• Device Sequence Number: 1
• Product Code: DTZ
• UDI-Device Identifier: 00699753450103
• UDI-Public: (01)00699753450103
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153213
• 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
• Report Date: 03/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3CX*RX25RE
• Device Catalogue Number: N/A
• Device Lot Number: 3A09
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/30/2023
• 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
• Treatment: ISTAT BLOOD GAS ANALYZER.
• Patient Outcome(s): Required Intervention; Other
• Patient Sex: Male
• Patient Weight: 86 KG