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

Model Number LN130B

Device Problem Difficult to Open or Close (2921)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/09/2017

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.For this reason, terumo references evaluation conclusion.(b)(4).

Event Description

The user facility reported to terumo cardiovascular that during cardiopulmonary bypass, the valve did not open up.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 june 29, 2017.(b)(4).The sample was not returned for evaluation.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.These units are also 100% visually inspected both during the leak testing step and during packaging.A retention sample from the same product code/lot number combination was obtained.The retention sample was manually run through each of these tests to determine if the umbrellas were functioning properly; all tests passed.Visual inspection was performed on the retention sample, during which no anomalies were noted.During assembly of ops valves, all duckbill valves are to be squeezed and confirmed to open prior to placing them into the housing.Ops valves are also 100% leak tested in process, during which a flow test is performed to confirm the duckbill opens and allows flow in the correct direction.This issue is currently undergoing an investigation; however, it is presently believed that the lack of flow through the duckbill valve is due to a process change in the water that the duckbills are washed in at the supplier.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.

Manufacturer Narrative

(b)(4).The investigation results and conclusions, previously reported, remain the same.

Event Description

(b)(4).

• 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: 6679419
• MDR Text Key: 78791623
• Report Number: 1124841-2017-00124
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 12/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2019
• Device Model Number: LN130B
• Device Catalogue Number: N/A
• Device Lot Number: VA23
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/01/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/23/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 1124841-06/25/2017-001-R
• Patient Sequence Number: 1