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 Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/22/2021

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.

Event Description

The user facility reported to terumo cardiovascular that during cardiopulmonary bypass, the vent valve leaked.It is unknown whether there was a delay in the procedure, if surgery was completed successfully or if there was any patient effect.There was a blood loss of 10cc.The blood filled the aortic root vent line to the overpressure safety valve and then stopped flowing.It was checked to see if it was a positional situation or the white mini roberts clamp was engaged.There were no problems identified.The positive and negative pressure relief valves were blocked in an attempt to open the duckbill.It appeared to open partially.They removed the overpressure safety valve from the line and replaced it with a straight connector to finish the procedure.The procedure concluded uneventfully.Terumo continues to attempt to gain more information regarding this event from the user facility.

Event Description

New information received that there was 30 minute delay in the procedure, the surgery was completed successfully and there was no patient effect or injury.

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 16, 2021.B3 (date of event) b5 (added describe event or problem) e1 (reporter name and address - added last name and email address) g3 (date received by manufacturer) g6 (indication that this is a follow-up report) h2 (follow-up due to additional information) h3 (device evaluation anticipated by manufacturer - 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.

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: (identification of evaluation codes 11, 3331, 4114, 3221, 4315).Type of investigation #1: 11 - testing of device from same lot/batch retained by manufacturer: type of investigation #2: 3331 - analysis of production records type of investigation #3: 4114 - device not returned investigation findings: 3221 - no findings available investigation conclusions: 4315 - cause not established the complaint sample was not returned for investigation.Ops valves are subject to a 100% leak test, which includes five different tests the units are run through to ensure there are no leaks and both the umbrellas and duckbills are functioning properly.The retention sample was visually inspected with no anomalies noted on the device.The retention sample was then manually run through the ops leak tests to ensure each component of the device is functioning as normal, the device functioned as intended.Without a retuned sample, a thorough investigation could not be performed and a root cause can not be determined.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: 11678599
• MDR Text Key: 249307501
• Report Number: 1124841-2021-00085
• 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: 05/21/2021

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: 08/31/2023
• Device Model Number: LN130B
• Device Catalogue Number: N/A
• Device Lot Number: YL14
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/23/2021
• Initial Date FDA Received: 04/16/2021
• Supplement Dates Manufacturer Received: 04/27/2021; 05/17/2021
• Supplement Dates FDA Received: 05/12/2021; 05/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1