MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION VALVE, O.P.S (STERILE) FOR TC; OVERPRESSURE SAFETY VALVE

Model Number LH130J

Device Problem Infusion or Flow Problem (2964)

Patient Problem No Patient Involvement (2645)

Event Date 11/30/2017

Event Type  malfunction  

Manufacturer Narrative

No patient involvement.Infusion or flow issue.Results pending completion of evaluation.Conclusion not yet available-evaluation in progress.

Event Description

The user facility reported to terumo cardiovascular that during other non-clinical activity, there was nonconformity of the duckbill valve.  no patient involvement.

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 january 12, 2018.(b)(4).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.(b)(4).Visual inspection was performed on the returned sample, during which no anomalies were noted anywhere on the device.Ops valves are subject to a 100% leak test, to ensure there are no leaks and both the umbrellas and duckbills are functioning properly.Upon evaluation of the returned sample, it was found to function as intended, and met all of the product specifications.Based on the complaint description, the suction or flow through the ops valve was not able to meet the specification during an inspection at distributor facility.This is believed to be an issue with the forward flow through the duckbill valve.The reported issue was not able to be replicated; therefore, the complaint was not confirmed.The cause of the issue with the duckbill is due to a process change at the supplier, specifically during the washing/cleaning step.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.

• Brand Name: VALVE, O.P.S (STERILE) FOR TC
• Type of Device: OVERPRESSURE SAFETY VALVE
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; 125 blue ball road; elkton MD 21921
• MDR Report Key: 7186648
• MDR Text Key: 97745349
• Report Number: 1124841-2018-00003
• Device Sequence Number: 1
• Product Code: DTL
• Combination Product (y/n): N
• PMA/PMN Number: K820297
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 02/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 03/31/2020
• Device Model Number: LH130J
• Device Catalogue Number: N/A
• Device Lot Number: VE03
• Other Device ID Number: (01)00699753450233
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2018
• Date Manufacturer Received: 02/01/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: 1124841-06/25/2017-001-R
• Patient Sequence Number: 1