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

Model Number LH130J

Device Problems Defective Device (2588); Infusion or Flow Problem (2964)

Patient Problem No Patient Involvement (2645)

Event Date 02/20/2018

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.(b)(4).

Event Description

The user facility reported to terumo cardiovascular that out of box, the duckbill valve was checked and found to be 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 march 28, 2018.Upon further investigation of the reported event, the following information is new and/or changed: device availability - added date returned to manufacturer.Application evaluated by manufacturer.Indication that this is a follow-up report.Follow-up due to additional information.Device evaluation anticipated by manufacturer - a second follow-up will be submitted upon completion of the investigation and/or submission of new information, thus tcvs references conclusions code 11.) 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, 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.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.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 the event, 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 valve 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.The new validated process has already been implemented at the supplier and terumo has initiated an action for removal of all affected units from the field 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: 7379483
• MDR Text Key: 103951881
• Report Number: 1124841-2018-00057
• 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: 04/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2018
• 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: VF01
• Other Device ID Number: (01)00699753450233
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2018
• Date Manufacturer Received: 04/18/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: 1124841-06/25/2017-001-R
• Patient Sequence Number: 1