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

Model Number LN130B

Device Problem Infusion or Flow Problem (2964)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The sample was not returned for evaluation; therefore, the complaint was not confirmed and a root cause was not able to be determined.From the complaint description, the issue seems to be with the lack of slit in the duckbill valve, which would then not allow flow through the valve during use.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.(b)(4).All available information has been placed on file in quality management for appropriate tracking, trending and follow-up.

Event Description

The user facility reported to terumo cardiovascular that prior to cardiopulmonary bypass, during setup, the ops valves in the tubing pack would not open.*no consequences or impact to patient, *product was not changed out.*procedure was completed successfully.

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 CORPORATION; 125 blue ball road; elkton MD 21921
• Manufacturer Contact: cathleen hargreaves ; 125 blue ball road; elkton, MD 21921 ; 8002837866
• MDR Report Key: 6749937
• MDR Text Key: 81249908
• Report Number: 1124841-2017-00161
• 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
• Report Date: 12/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2017
• 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
• Date Manufacturer Received: 12/01/2017
• 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
• Removal/Correction Number: 1124841-06/25/2017-001-R
• Patient Sequence Number: 1