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

Model Number LN130BJ

Device Problem Leak/Splash (1354)

Patient Problem No Patient Involvement (2645)

Event Date 09/27/2017

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).Results: results pending completion of evaluation.Conclusions: conclusion not yet available-evaluation in progress.

Event Description

The user facility reported to terumo cardiovascular that prior to cardiopulmonary bypass, during prime, that there was a leak on the overpressure safety valve.No patient involvement as this occurred during prime.Product was changed out.Procedure was completed successfully.

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: (b)(4).The returned sample was visually inspected.Slight deformation/damaged was found to one of the ports.The returned sample passed all leak tests and met all specifications therefore the complaint was not confirmed and the actual root cause can not be determined.It is possible that the unit had been over pressurized during use, causing the unit to leak.The other possibility would be the ops valve was placed in an aortic root vent line and the vent line was not properly clamped, therefore causing a positive pressure buildup in the vent line.The positive pressure relief valve then opened to release the pressure, and cause the ops valve to leak.This may have been the cause of the reported leak, if the valve was used in the aortic root vent line.However, a definitive root cause could not be determined.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 ¿ and as indicated by terumo cardiovascular systems in the initial report submitted to the fda on october 20, 2017.A second follow-up will be submitted upon completion of the investigation and/or submission of new information.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 FOR TC
• Type of Device: OVERPRESSURE SAFETY VALVE
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; 125 blue ball road; elkton MD 21921
• Manufacturer Contact: cathleen hargreaves ; 125 blue ball road; elkton, MD 21921 ; 8002837866
• MDR Report Key: 6965976
• MDR Text Key: 90673401
• Report Number: 1124841-2017-00212
• Device Sequence Number: 1
• Product Code: DTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K820297
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 11/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2020
• Device Model Number: LN130BJ
• Device Catalogue Number: N/A
• Device Lot Number: VC13
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/16/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/13/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1