MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION STERILE NX19RE W/ 4L RES; BLOOD GAS OXYGENATOR

Model Number	3CX*NX19RE
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Codes	Blood Loss (2597); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/03/2020
Type of Reportable Event	Malfunction
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); (b)(4).Results: results pending completion of investigation; conclusions:conclusion not yet available.
Event or Problem Description
The user facility reported to terumo cardiovascular that during cardiopulmonary bypass, a plasma leakage occurred.Per used facility, the procedure was a reconstruction of the mitralis valve with the da vinci robot.The amount of blood loss was minimal, about 230ml, but was recovered by the cell saver.The total cpb-time was: 376 min and clamp time 230 min.After about 300 min the plasma leakage was detected, see also attached movies.The temperature of the patient was at that moment 31° c.There was no problem with the gas exchange performance, no issues seen.The product was not changed out; the surgery was completed successfully.
Additional 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: b1 (report type - corrected - product problem only) d4 (additional device information - added expiration date) g3 (date received by manufacturer) g6 (indication that this is a follow-up report) h2 (follow-up due to additional information) h3 (device evaluated by manufacturer) h4 (device manufacture date) h6 (identification of evaluation codes 2199, 10, 3331, 4210, 4315) health effect - impact code - corrected - 2199 - no health consequences or impact type of investigation #1:10 - testing of actual/suspected device type of investigation #2: 3331 - analysis of production records investigation findings: 4210 - leakage/seal investigation conclusions: 4315 - cause not established on this and similar complaints, no significant visual anomalies have been noted on receipt.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.An engineering investigation and a capa have been initiated and is currently working to determine a root cause.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.
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 december 23, 2020.Upon further investigation of the reported event, the following information is new and/or changed: h6 (identification of codes 4739, 4614, 4582, 1354, 11).H6: component code: 4739 - gas exchanger, health effect - impact code: 4614 - serious injury/ illness/ impairment, health effect - clinical code: 4582 - no clinical signs, symptoms or conditions, medical device problem code:1354 - leak/splash, investigation conclusions: 11 - conclusion not yet available.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.
Event or Problem Description
New information received from the pump record/ cpb graph show that the approximate start of leakage was about 5 hours after the start of cardiopulmonary bypass.

• Brand Name: STERILE NX19RE W/ 4L RES
• Common Device Name: BLOOD GAS OXYGENATOR
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; 125 blue ball road; elkton MD 21921
• MDR Report Key: 11065231
• Report Number: 1124841-2020-00292
• Device Sequence Number: 16803359
• Product Code: DTZ
• UDI-Device Identifier: 00699753450868
• UDI-Public: (01)00699753450868
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K180950
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/17/2021

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: 09/30/2023
• Device Model Number: 3CX*NX19RE
• Device Catalogue Number: N/A
• Device Lot Number: YM05
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/09/2020
• Supplement Date Received by Manufacturer: 01/04/2021; 02/05/2021
• Initial Report FDA Received Date: 12/23/2020
• Supplement Report FDA Received Date: 01/26/2021; 02/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CELL SAVER; CELL SAVER
• Patient Age: 67 YR