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

Model Number 3CX*RX25RE

Device Problems Gas Output Problem (1266); Leak/Splash (1354)

Patient Problems Hemorrhage/Bleeding (1888); Hypoxia (1918)

Event Date 04/05/2022

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.(b)(4).

Event Description

The user facility reported to terumo cardiovascular that during cardiopulmonary bypass the oxygenator failed.Per user facility the patient was in for a mini mitral valve replacement was in for a mini mitral valve replacement which was successfully completed.He had severe aortic insufficiency and the pump suckers were turned to a high rpm.The patient was cooled to 28c no xclamp, and cold fibrillatory arrest occurred.After 1.5 to 2 hours into the case, the arterial pco2 started to rise on the cdi 500, with the shunt sensor having undergone a passing 2 point calibration before bypass.The gas sweep was raised up and over 10l/min with the epgs on system 1 hlm with no effect to lower the pco2, even after reducing co2 flushing to the field.A point of care blood gas analyzer confirmed pco2 in the 70s.Gas flow was confirmed exiting the system 1 hlm by the external flowmeter and also holding the gas line to the ear for the physical presence of gas flow out from the gas line and gas filter.The heparinization of the blood was adequate and confirmed by acts and also heparin concentration using hepcon.The decision was made to go to a oxygen tank directly to the oxygenator at 15-20 l/min.This action did not reduce the rising pco2.The surgeons noted that the blood color started to look dark.A decision was made to switch out the rx oxygenator without changing the reservoir upon changing the oxygenator, a blood leak occurred from an open purge line off the oxygenator.In the instant of the leak, and trouble not determining the source of the leak, the oxygenator was again changed quickly, however not due to gas exchange performance but due to the blood leak itself.The third oxygenator was primed and the patient placed back on bypass.The gas source was still the oxygen tank.The gas exchange at this point became acceptable, with ph, pc02 and po2 all falling within acceptable ranges.An estimated blood loss of 500 to 700 ml did occur in this case at this point.A decision was made to switch the gas source back to the system 1 epgs.The blood gases at this point started to deteriorate once again, so the o2 tank was once again utilized to source 100 percent oxygen to the patient.The blood gases became acceptable again the surgery was successfully completed.The product was change out.Surgery 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 april 26, 2022.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 samples were inspected upon receipt to show no visual anomalies with either device.After rinsing and drying the samples, the samples were built into a circuit with bovine blood and tested for gas transfer performance at applicable flow levels.Both samples met factory specifications for oxygen transfer and carbon dioxide removal.As the event could not be replicated in laboratory conditions, it is not possible to determine a 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: 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: 14204061
• MDR Text Key: 290041956
• Report Number: 1124841-2022-00094
• 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: 06/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2022
• 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: ZN01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/09/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/04/2021
• 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
• Treatment: RADIOMETER 90, SYSTEM 1 HLM, HEPCON
• Patient Outcome(s): Other
• Patient Sex: Male
• Patient Weight: 100 KG