MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION VALVE, O.P.S BULK, N-S; OVERPRESSURE SAFETY VALVE

Model Number LN130B

Device Problem Leak/Splash (1354)

Patient Problems Blood Loss (2597); No Information (3190)

Event Date 07/24/2020

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 the line number 3 of the vent valve leaked.It is unknown when this event occurred, whether the product was changed out, whether the surgery was completed successfully or if there was any patient effect.Terumo continues to attempt to gain more information regarding this event from the user facility.

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 september 13, 2020.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.

Event Description

Additional information received: the event occurred during cardiopulmonary bypass, there was no delay in the procedure, the product was changed out and the surgery was completed successfully however there was 2cc blood loss.

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 codes11, 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 complaint sample was not returned for investigation.The retention sample was found to function as intended, and met all of the product specifications.The complaint was not confirmed.All ops valves are subjected to a 100% leak test that undergoes 5 separate programs to test that each component in the valve is functioning properly.These units are also 100% visually inspected both during the leak testing step and during packaging.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.

• Brand Name: VALVE, O.P.S BULK, N-S
• Type of Device: OVERPRESSURE SAFETY VALVE
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; 125 blue ball road; elkton MD 21921
• MDR Report Key: 10404312
• MDR Text Key: 202950749
• Report Number: 1124841-2020-00186
• Device Sequence Number: 1
• Product Code: DTL
• Combination Product (y/n): N
• PMA/PMN Number: K820297
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 10/09/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2022
• Device Model Number: LN130B
• Device Catalogue Number: N/A
• Device Lot Number: XG24
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/24/2020
• Initial Date FDA Received: 08/13/2020
• Supplement Dates Manufacturer Received: 09/09/2020; 10/07/2020
• Supplement Dates FDA Received: 09/29/2020; 10/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1