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 Patient Involvement (2645)
Date of Event	06/30/2020
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).
Event or Problem Description
The user facility reported to terumo cardiovascular that prior to cardiopulmonary bypass, during setup, there was a leak at water connector of the oxygenator.No patient involvement.The product was 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: d10 (device availability - added date returned to manufacturer).G4 (date received by manufacturer).G7 (indication that this is a follow-up report).H2 (follow-up due to additional information).H3 (device evaluation anticipated by manufacturer - a third 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.
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 july 17, 2020.Upon further investigation of the reported event, the following information is new and/or changed: d4 (additional device information - added expiration date).G4 (date received by manufacturer).G7 (indication that this is a follow-up report).H2 (follow-up due to additional information).H4 (device manufacture date).H6 (identification of evaluation codes 11, 3331, 4114, 3221, 4315).Method code #1: 11 - testing of device from same lot/batch retained by manufacturer.Method code #2: 3331 - analysis of production records.Method code #3: 4114 - device not returned.Results code: 3221 - no findings available.Conclusions code: 4315 - cause not established.The affected sample was not returned so a thorough investigation could not be performed.A representative retention sample was used for past testing that involved connection to the water ports.No water leakage was observed during a multi-hour test.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.Upon further investigation of the reported event, the following information is new and/or changed: h6 (identification of evaluation codes 10, 3259, 25).Method code #1: 10 - testing of actual/suspected device.Results code: 3259 - improper physical structure.Conclusions code: 25 - cause traced to manufacturing.The affected sample was inspected upon receipt with no visual anomalies.The unit was tested per procedure to reveal leakage from the gas out endcap.Dissection of the unit revealed a void in the endcap gluing.Since the production of the affected sample, changes have taken place to address issues with the end cap gluing process.A review of the barcode records for this serial number showed that the unit passed all steps of the manufacturing testing process.A representative retention sample was used for past testing that involved connection to the water ports.No water leakage was observed during a multi-hour test.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: 10290119
• Report Number: 1124841-2020-00166
• Device Sequence Number: 11324267
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 11/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2020
• Device Model Number: 3CX*NX19RW
• Device Catalogue Number: N/A
• Device Lot Number: XH29
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/01/2020
• Supplement Date Received by Manufacturer: 08/20/2020; 08/31/2020; 11/20/2020
• Initial Report FDA Received Date: 07/17/2020
• Supplement Report FDA Received Date: 08/27/2020; 09/21/2020; 11/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1