MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION STERILE NX19RW W/4L RESERVOIR; BLOOD GAS OXYGENATOR

Model Number 3CX*NX19RW

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

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 05/21/2021

Event Type  Death  

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 a plasma leakage.The operation was an aorta dissection, which was an acute situation.The total cardiopulmonary bypass (cpb) time was 434 minutes, at approximately 330 minutes the leakage appeared.Initially, a co2-removal problem appeared during the rewarding phase of the surgical procedure, indicating increased gas flow rates at gas line pressures above 25 mmhg.Subsequently, plasma leakage was noted at the gas outlet port.There was delay during the procedure; for the nx19 needed to be replaced due to oxygenator failure.The exchange was performed during a quick circulatory discontinuation of 45 seconds.Impact on the surgical procedure as such is therefore not assessable.The surgery was not completed.The patient expired on the operating table.The product was changed out.There was a blood loss of approximately 185 ml.

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 june 10, 2021.  upon further investigation of the reported event, the following information is new and/or changed: d9: (device availability - added date returned to manufacturer).G3: (date received by manufacturer).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: b5 (updated describe event or problem).D4 (additional device information - added exp date).G3 (date received by manufacturer).G6 (indication that this is a follow-up report).H2 (follow-up due to correction, additional information and device evaluation).H3 (device evaluated by manufacturer).H4 (device manufacture date).H6 (identification of evaluation codes 1266, 10, 11, 3331, 213, 67).Medical device problem code: 1266 - gas output problem.Type of investigation #1: 10 - testing of actual/suspected device.Type of investigation #2: 11 - testing of device from same lot/batch retained by manufacturer.Type of investigation #3: 3331 - analysis of production records.Investigation findings: 213 - no device problem found.Investigation conclusions: 67 - no problem detected.The affected sample was inspected upon receipt with no significant anomalies observed.The unit was then decontaminated and tested for gas transfer performance.The affected sample achieved oxygen transfer values of 288.4 ml/min at 4lpm and 488.2 ml/min at 8lpm and carbon dioxide transfer values of 210.9 ml/min at 4lpm and 320.9 ml/min at 8lpm.These values meet the specification of 49 ml/min of oxygen transfer and 38 ml/min of carbon dioxide transfer.A representative retention sample was inspected with no anomalies and was then built into a circuit with bovine blood and tested for gas transfer performance.It achieved an oxygen transfer values of 737.5 ml/min at 7 lpm and a carbon dioxide transfer value 371.1 ml/min at 7 lpm.These values meet the specification of 49 ml/min of oxygen transfer and 38 ml/min of carbon dioxide transfer.The clinical pump record or the copy of perfusion record was not provided; therefore, the evaluation of the specific case details are limited.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.

Event Description

Additional information received that there was a gas transfer performance issue.

• Brand Name: STERILE NX19RW W/4L RESERVOIR
• Type of Device: BLOOD GAS OXYGENATOR
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; 125 blue ball road; elkton MD 21921
• MDR Report Key: 11973437
• MDR Text Key: 255327613
• Report Number: 1124841-2021-00135
• Device Sequence Number: 1
• Product Code: DTZ
• UDI-Device Identifier: 00699753450875
• UDI-Public: (01)00699753450875
• Combination Product (y/n): N
• PMA/PMN Number: K180950
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 08/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2023
• Device Model Number: 3CX*NX19RW
• Device Catalogue Number: N/A
• Device Lot Number: ZA25
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death