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

Model Number 3CX*FX25RWC

Device Problem Use of Device Problem (1670)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 03/08/2023

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 11.Adverse event problem: component code: 4739 - gas exchanger; health effect - impact code #1: 4614 - serious injury/ illness/ impairment; health effect - impact code #2: 4643 - blood transfusion; health 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.

Event Description

The user facility reported to terumo cardiovascular that during cardiopulmonary bypass, the pao2 decreased after 90 minutes on pump with normal pao2 levels at the beginning from 304 to 86 mmhg at the end of the cpb.Per facility, this event occurred in normal patient´s conditions; including hematocrit levels between 26% and 35%, temperature in arterial blood of 36.5°c at maximum value; blood flow of 4.4 lpm in average corresponding to cardiac index 2.7 lt/min/m2, with good tca levels minimum level of 501 with administration of new doses of heparin.The lactato levels in cpb in max value 1.9.The pao2 drop was supported for increase in fio2 from 80% to 100%, blood transfusions and blood flow increase from 4.4 lpm to 4.8 lpm corresponding to cardiac index 3 lt/min/m2.This event was monitoring with cdi500 with arterial and venous shunt sensor and ½ inch cuvette.The blood arterial pressure was supporting with noradrenaline at 1 mcg/kg/min as maximum dose during cpb.The cpb was finished with pao2 in 336 mmhg supported for anesthesia machine at fio2 100% and membrane oxygenator with fio2 at 100% too.The perfusionist didn´t change out the membrane oxygenator and the surgical procedure was finished and the pao2 taken immediately at the end of the cpb in the radial arterial line was of 350 mmhg and the lactato levels was 2.3 in the immediate period.This event has been similar to previously reported with the same reference a few weeks ago, the lot is different, and the verification of the oxygen and air level was made.They used a fio2 sensor in the oxygen line and the fio2 was the same in ranges to electronic blender levels.They have been supporting 3 cases with bioengineer and clinical specialist, including cdi500 in those cases and this last showed the low pao2 level.The product was not changed out they mitigated the issue with anesthesia fio2 support at 100%.Blood loss occurred due to a surgeon-associated event with ventricular rupture previous to cpb and this triggered the first transfusion requirements, this volume loss was approximately 700 ml.The transfusion during cpb was performed to maintain hto and do2 levels in optimal conditions.They had blood transfusion at 1182ml.There was 700ml of blood loss.The product was not changed out.The surgery was completed successfully.

Event Description

Additional information from the clinical specialist states that, on the review of the pump record provided the following information: the patient is a 23-year-old female with a height of 163cm and weight of 55kg, resulting in a bsa of 1.58m2.The patient was undergoing bypass surgery for an atrial septal defect.During the surgery, there was a surgeon related ventricular rupture that resulted in a blood loss of 700ml and necessitated the transfusion of 1182ml of blood.The pump run was 118 minutes long.The patient was kept normothermic throughout bypass and hematocrits ranged from 25 to 28 percent with blood transfusions.The pump record has limited information on event times.The patient¿s intubated po2 pre-bypass was 231mmhg at 9:12am.The first custodial cardioplegia dose was delivered at 11:10am.At 11:20am, the po2 on bypass was 299mmhg with a fio2 of 90 percent.At 12:09pm, the po2 was 178mmhg with a fio2 of 55 percent.These po2 values must have been from the blood gas lab or from a point of care blood gas device.The cdi500 po2 value at 12:09pm was 311mmhg.The cdi 500 po2 results from 12:09pm to 13:43 do reveal a steadily decreasing trend to a po2 low of approximately 90mmhg with a fio2 of 100 percent.From the cdi 500 results, the lowest arterial saturation was 96 percent with the oxygenator.The oxygenation of the patient was aided with the anesthesia ventilator at 100 percent towards the end of the bypass run, and the cdi500 po2 measured 336mmhg, arterial saturations at 100 percent, at 13:51.Per the pump record provided, only 2 act values seem to have been done for the entire case, one at 11:51am with a result of 579 seconds and one at 11:55am with a result of 501 seconds.From the cdi500 results, it seems bypass was terminated approximately before 14:00.There are no entries of additional heparin amounts given on the pump record.Nor are there additional act values entered.The perfusionist hemoconcentrated this patient and removed 1010ml of ultrafiltrate.

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 30 ,2023.Upon further investigation of the reported event, the following information is new: 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 finding: 213 - no device problem found.Investigation conclusions: 67 - no problem detected.The actual sample was visually inspected and found no anomaly such as breakage.After rinsed and dried, the sample was tested for oxygen transfer and carbon dioxide removal performance in accordance with the product inspection protocol.Based on the investigation result, the gas transfer performance met the factory's specifications.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.

• Brand Name: STERILE FX25RWC W/ 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: 16644715
• MDR Text Key: 312364880
• Report Number: 1124841-2023-00079
• Device Sequence Number: 1
• Product Code: DTZ
• UDI-Device Identifier: 00699753450837
• UDI-Public: (01)00699753450837
• Combination Product (y/n): N
• Reporter Country Code: EC
• PMA/PMN Number: K151791
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3CX*FX25RWC
• Device Catalogue Number: N/A
• Device Lot Number: 2M31
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/08/2023
• Initial Date FDA Received: 03/30/2023
• Supplement Dates Manufacturer Received: 05/01/2023
• Supplement Dates FDA Received: 05/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/02/2002
• 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; Other
• Patient Age: 23 YR
• Patient Sex: Female
• Patient Weight: 55 KG
• Patient Ethnicity: Hispanic
• Patient Race: White