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 Patient Involvement (2645)
Date of Event	07/27/2018
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
The user facility reported to terumo cardiovascular that during setup, the valve was unable to suction.No patient involvement.Product was changed out.Procedure was 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 august 21, 2018.(b)(4).All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.
Additional Manufacturer Narrative
This follow-up report is submitted to fda in accord with applicable regulations.(b)(4).The sample was returned and visually inspected.It was noted to have damage to the negative pressure umbrella the umbrella appeared to be "pushed" into the ops housing and not properly seated onto the negative housing area within the part.The sample was placed into a vent line in an attempt to recreate the event; the sample was unable to suction during use.The duckbill valve was tested for opening pressure.The valve was set-up with negative vacuum/suction on the duckbill to check the opening pressure without manipulating the miss-seated negative umbrella valve.The duckbill opened within specification with 86 mmhg of negative pressure (the specification is 0-99 mmhg; positive or negative).This confirmed the failure mode as the negative umbrella valve.The retention sample was investigated in the same manner, with no visual anomalies noted on the positive or negative pressure umbrellas.The retention sample was placed into a vent line and found to produce suction as expected.The duckbill valve was tested for opening pressure.The valve was set-up with negative vacuum/suction on the duckbill to check the opening pressure without manipulating the miss-seated negative umbrella valve.The duckbill opened within specification with 21 mmhg of negative pressure (the specification is 0-99 mmhg; positive or negative).This confirmed the failure mode as the negative umbrella valve.The returned sample was found to leak from the negative umbrella because it was not seated properly in the housing.This would have caused the ops valve to not suction during the event as air was leaking past the negative umbrella rather than suctioning blood.All ops valves are subjected to a 100% leak test that undergoes 5 separate programs to test that each component in the valve is functioning properly.These units are also 100% visually inspected both during the leak testing step and during packaging.A potential root cause could be that the negative pressure umbrella was damaged prior to use, causing the unit to leak.The investigation results and conclusions, it was determined that the failure mode was not related to the removal, 1124841-06/25/2017-001-r.The investigation found that the unit leaked from the negative umbrella as it was not seated in the housing properly.This is not related to the duckbill not allowing flow through the valve; therefore, it has been determined that this event is not related to the removal.

• 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: 7803840
• Report Number: 1124841-2018-00194
• Device Sequence Number: 16766376
• 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,Followup
• Report Date (Section B): 10/11/2018

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: 12/31/2019
• Device Model Number: LH130J
• Device Catalogue Number: N/A
• Device Lot Number: VA30
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/02/2018
• Supplement Date Received by Manufacturer: 08/21/2018; 10/09/2018
• Initial Report FDA Received Date: 08/21/2018
• Supplement Report FDA Received Date: 09/07/2018; 10/11/2018
• 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