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

Model Number	LH130J
Medical Device Problem Code	Suction Failure (4039)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/13/2018
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
The user facility reported to terumo cardiovascular that during cardiopulmonary bypass, the safety valve was unable to suction.The valve was removed and the procedure was continued without using the valve.*no consequence to patient, *product was not changed out , *procedure completed successfully.
Additional 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 noted that there was dried blood located in the slit of the duckbill valve.No other anomalies were noted 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.The returned sample was manually run through each of these tests.During the duckbill leak test, when the inlet portion of the ops was clamped off while maintaining the pressure of 3.5 psi, a leak was noted at 1 psi.All other tests passed and met product specifications.After completing the remaining tests, the duckbill leak test was re run and during the second attempt, no leaks were observed and the test passed.This is most likely attributed to the dried blood within the duckbill valve being released during subsequent functionality tests.A retention sample from the same product code and lot number combination was obtained.No visual anomalies were noted with the retention sample.The retention sample was also manually run through the same five tests as the returned sample.All tests passed and met product specifications.The reported issue was not able to be replicated; therefore, the complaint was not confirmed.Additionally, the presence of blood within the duckbill slit indicates that the valve did open/suction at some point during the case.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
• Common Device Name: OVERPRESSURE SAFETY VALVE
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; 125 blue ball road; elkton MD 21921
• MDR Report Key: 7844829
• Report Number: 1124841-2018-00210
• Device Sequence Number: 11146943
• Product Code: DTL
• UDI-Device Identifier: 00699753450233
• UDI-Public: (01)00699753450233
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K820297
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 10/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 03/31/2020
• Device Model Number: LH130J
• Device Catalogue Number: N/A
• Device Lot Number: VF01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/17/2018
• Supplement Date Received by Manufacturer: 10/19/2018
• Initial Report FDA Received Date: 09/05/2018
• Supplement Report FDA Received Date: 10/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 1124841-06/25/2017-001-R
• Patient Sequence Number: 1