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

Model Number 3CX*NX19RW

Device Problem Defective Component (2292)

Patient Problem No Patient Involvement (2645)

Event Date 11/01/2019

Event Type  malfunction  

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 Description

The user facility reported to terumo cardiovascular that prior to cardiopulmonary bypass, during setup, the priming purge line came apart.As per user facility, the purge line of the oxygenator where the one way valve is located was not sealed.When he was setting it up, it came apart.No patient involvement.The product was changed out.The surgery was completed successfully.

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 november 19, 2019.Upon further investigation of the reported event, the following information is new and/or changed: (identification of evaluation codes 11, 3331, 4114, 3259, 4307) 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: 3259 improper physical structure.Conclusions code: 4307 cause traced to component failure.The affected sample was not returned, so a thorough investigation could not be performed.Pictures provided with the complaint were used to confirm the event.A representative retention sample was reviewed and the one-way valve was confirmed to be intact.The supplier was sent a notification to make them aware of the 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
• Type of Device: BLOOD GAS OXYGENATOR
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; 125 blue ball road; elkton MD 21921
• MDR Report Key: 9344031
• MDR Text Key: 168837838
• Report Number: 1124841-2019-00313
• Device Sequence Number: 1
• Product Code: DTZ
• UDI-Device Identifier: 00699753450875
• UDI-Public: (01)00699753450875
• Combination Product (y/n): N
• PMA/PMN Number: K180950
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 12/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2020
• Device Model Number: 3CX*NX19RW
• Device Catalogue Number: N/A
• Device Lot Number: XH22
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1