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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/07/2021
Type of Reportable Event	Death
Additional 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 or Problem Description
It was reported to terumo cardiovascular that during cardiopulmonary bypass, there was a plasma leak.It was a long procedure (364 minutes) with several changes between off and on pump and the perfusionist changed also during the procedure.It was planned to be a tavi procedure without ecc.The patient was in a very bad condition and had multiple co-morbidities.During the procedure the native circulation collapsed and it was decided to take the patient on bypass to give circulatory support.They tried to wean the patient several time without success.The procedure included several low flow phases and also intermittent time of internal circulation of the hlm.The performance of the oxygenator was not affected.The patient expired.It is still unknown whether there was a delay in the procedure, whether the product was changed out or whether there was blood loss as a result of the procedure.Terumo continues to attempt to gain more information regarding this event from the user facility.The surgery was completed successfully.
Additional 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 27, 2021.Significant evaluation has been conducted to determine the potential cause of the reported events.There has been multiple laboratory tests and evaluations.An exact cause of the plasma leakage could not be determined at this time.A capa is in progress to determine a root cause of this phenomenon and explore methods to reduce the occurrence of this event.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.

• 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: 11733413
• Report Number: 1124841-2021-00093
• Device Sequence Number: 11868952
• Product Code: DTZ
• UDI-Device Identifier: 00699753450875
• UDI-Public: (01)00699753450875
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K180950
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/10/2021

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 Model Number: 3CX*NX19RW
• Device Catalogue Number: N/A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/08/2021
• Supplement Date Received by Manufacturer: 06/09/2021
• Initial Report FDA Received Date: 04/27/2021
• Supplement Report FDA Received Date: 06/10/2021
• 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