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 07/19/2018

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.(b)(4).

Event Description

The user facility reported to terumo cardiovascular that during out of box, a duckbill valve was defective.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 september 4, 2018.(b)(4).The returned sample was visually inspected and there were no visual anomalies observed on the complaint sample.The outlet end of the ops was left open while submerged under water.The line was pressurized until bubbles could be seen from the outlet of the ops, which occurred at 11 mmhg.This tested the flow of the duck bill, and the specification has a maximum of 99mmhg; the test passed.The duckbill was also functioning as intended with not allowing back flow; positive pressure was released through the positive umbrella at roughly 300 mmhg.The retention sample was evaluated in the same manner and found to meet tcvs specifications for flow of the duckbill.All ops valves undergo 100% leak test and visual inspection.There is a known issue currently ongoing with the duckbill valve within the ops valve, that prevents the duckbill from opening within the product specification range.It is possible that the duckbill valve did not open during inspection, as reported; however, if a high enough pressure had been reached after that initial attempt, the seal in the slit of the duckbill may have been broken, allowing the device to pass all leak tests during the evaluation of the returned sample.This was not able to be 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: 7844344
• MDR Text Key: 119336959
• Report Number: 1124841-2018-00208
• Device Sequence Number: 1
• Product Code: DTL
• UDI-Device Identifier: 00699753450233
• UDI-Public: (01)00699753450233
• 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
• Report Date: 10/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 09/30/2020
• Device Model Number: LH130J
• Device Catalogue Number: N/A
• Device Lot Number: VM02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/09/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: 1124841-06/25/2017-001-R
• Patient Sequence Number: 1