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

Model Number 3CX*NX19RW

Device Problem 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

The returned sample was inspected upon receipt with no significant anomalies observed.Both the returned sample and representative retention sample met the factory specifications for the gas transfer performance tests.For the plasma leakage, significant evaluation has been conducted to determine the potential cause of the reported events and there has been multiple laboratory tests and evaluations.An exact cause of the plasma leakage could not be determined at this time.(b)(4).All available information has been placed on file in quality management for appropriate tracking, trending and follow-up.

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 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.

• 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
• Manufacturer (Section G): SAME
• Manufacturer Contact: jamie quinlan ; 125 blue ball road; elkton, MD 21921 ; 8002837866
• MDR Report Key: 12377223
• MDR Text Key: 268458841
• Report Number: 1124841-2021-00203
• Device Sequence Number: 1
• Product Code: DTZ
• UDI-Device Identifier: 00699753450875
• UDI-Public: (01)00699753450875
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K180950
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/27/2021

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 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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/12/2021
• Initial Date FDA Received: 08/27/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/25/2021
• 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
• Patient Outcome(s): Death