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 Known Impact Or Consequence To Patient (2692)

Event Date 10/22/2017

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).

Event Description

The user facility reported to terumo cardiovascular that prior to cardiopulmonary bypass, during prime, the overpressure safety valve leaked priming solution.No known impact or consequence to patient.Product was changed out.Procedure 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 27, 2017.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.The returned sample was visually inspected, tip of the outlet port found slightly deformed, no other anomalies were noted.Ops valves are subject to a 100% leak test, to ensure there are no leaks and both the umbrellas and duckbills are functioning properly.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 vent line and not properly clamped causing a positive pressure building up the vent line.The positive pressure relief valve opened to release the pressure, and causes the valve to leak.This may have been the cause of the reported leak, if the valve was used in the aortic vent line.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 rd; elkton MD 21921
• Manufacturer Contact: cathleen hargreaves ; 125 blue ball rd; elkton, MD 21921 ; 8002837866
• MDR Report Key: 7060539
• MDR Text Key: 93249633
• Report Number: 1124841-2017-00244
• 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 Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2020
• Device Model Number: LN130BJ
• Device Catalogue Number: N/A
• Device Lot Number: VF08
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/04/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/08/2017
• 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