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

Model Number LN130B

Device Problem Leak/Splash (1354)

Patient Problem Blood Loss (2597)

Event Date 03/16/2017

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 during cardiopulmonary bypass, the valve line is leaking.*blood loss of 2cc, *product was changed out, *procedure was completed successfully.

Manufacturer Narrative

The sample was not returned for evaluation; therefore, the complaint was not confirmed and a definitive root cause was not determined.A retention sample from the same product code/lot number combination was obtained.Visual inspection was performed on the retention sample, during which no anomalies were noted anywhere on the device.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 manually run through each of these tests.The retention sample passed all leak tests and met all specifications.During the investigation of a similarly reported event, simulation testing of the ops valve in an aortic root vent line found the ops valve to leak if the vent line was not properly clamped during cardioplegia delivery, and there was possible pressure buildup in the heart causing a positive pressure buildup in the vent line.The positive pressure relief valve then opened to release the pressure, and caused the ops valve to leak.If the ops valve for this reported event was used in the aortic root vent line, this same event may have occurred; however, the line that the affected valve was used in was not provided.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 CORP.; 125 blue ball road; elkton MD 21921
• Manufacturer Contact: cathleen hargreaves ; 125 blue ball road; elkton, MD 21921 ; 8002837866
• MDR Report Key: 6487852
• MDR Text Key: 72676910
• Report Number: 1124841-2017-00058
• 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,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/12/2017

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: 06/30/2019
• Device Model Number: LN130B
• Device Catalogue Number: N/A
• Device Lot Number: UH25
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/24/2017
• Initial Date FDA Received: 04/12/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/12/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/25/2016
• 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