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

Model Number	3CX*NX19RW
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	05/21/2021
Type of Reportable Event	Death
Additional 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 or Problem 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
• Common Device Name: BLOOD GAS OXYGENATOR
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; 125 blue ball road; elkton MD 21921
• MDR Report Key: 12377223
• Report Number: 1124841-2021-00203
• Device Sequence Number: 17135004
• Product Code: DTZ
• UDI-Device Identifier: 00699753450875
• UDI-Public: (01)00699753450875
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K180950
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/12/2021
• Initial Report FDA Received Date: 08/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death