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 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).Results: results pending completion of evaluation.Conclusions: conclusion not yet available-evaluation in progress.

Event Description

The user facility reported to terumo cardiovascular that prior to cardiopulmonary bypass, during setup, the safety valve in an elevation differential vent circuit did not perform suction.The part of the safety valve was cut, and the circuit was re-connected without the safety valve.After that, the vent circuit started to perform suction successfully and the procedure was successfully completed.No patient involvement as this occurred during setup.Product was not 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 15, 2018.(b)(4).A second follow-up will be submitted upon completion of the investigation and/or submission of new information.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 of the returned sample was performed, in which no anomalies were noted.Ops valves are subject to a 100% leak test, which includes five different tests to ensure there are no leaks and both the umbrellas and duckbills are functioning properly.A retention sample form the same product code and lot number combination was obtained, visually inspected, and also run through the same leak tests.Based on the evaluation, it was found to function as intended, and met all of the product specifications.The reported issue was not able to be replicated; therefore, the complaint was not confirmed.This is believed to be an issue with the forward flow through the duckbill valve.All ops valves undergo 100% leak test and visual inspection.There is a known issue with an identified quantity of the duckbill valves 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 setup, 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.However, this was not able to be confirmed.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: 7605425
• MDR Text Key: 111318794
• Report Number: 1124841-2018-00120
• 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,foreig
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 08/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2018
• 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: LH130J
• Device Catalogue Number: N/A
• Device Lot Number: VA02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/02/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: 1124841-06/25/2017-001-R
• Patient Sequence Number: 1