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 Blood Loss (2597)

Event Date 07/21/2017

Event Type  malfunction  

Manufacturer Narrative

Terumo has received the device for evaluation; however, 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.For this reason, terumo references (b)(4).

Event Description

The user facility reported to terumo cardiovascular that during cardiopulmonary bypass, the vent valve leaked.There was a blood loss of 5 cc, 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 august 09, 2017.(b)(4).Visual inspection was performed on the returned sample, during which no anomalies were noted, other than dried blood within the valve.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 returned sample was manually run through each of these tests to determine if the umbrellas were functioning properly; all tests passed.A retention sample from the same product code/lot number combination was run through the same tests and confirmed to pass each of the 5 leak tests.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 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.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
• Manufacturer Contact: cathleen hargreaves ; 125 blue ball road; elkton, MD 21921 ; 8002837866
• MDR Report Key: 6778483
• MDR Text Key: 82599037
• Report Number: 1124841-2017-00172
• 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: 09/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2020
• Device Model Number: LN130B
• Device Catalogue Number: N/A
• Device Lot Number: VD20
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/22/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/20/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1