MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION VALVE, O.P.S BULK, N-S FOR TC; OVERPRESSURE SAFETY VALVE

Model Number LN130BJ

Device Problem Leak/Splash (1354)

Patient Problem Blood Loss (2597)

Event Date 10/02/2020

Event Type  Injury  

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 code 11.(b)(4).

Event Description

The user facility reported to terumo cardiovascular that during cardiopulmonary bypass, they noticed blood leaked.When the pump of the vent was circulated, blood did not flow to the pump side past the ops valve, and blood was leaking.The user covered the positive pressure relief valve and the negative pressure relief valve with fingers, and blood began to flow to the pump side.After that, the valve was able to suction successfully.Approximately 200ml of blood loss.Product was not changed out.Procedure was completed successfully.

Manufacturer Narrative

This follow-up report is submitted to fda in accord with applicable regulations.Upon further investigation of the reported event, the following information is new and/or changed: h6 (identification of evaluation codes 10, 11, 3331, 213, 67).Method code #1: 10 - testing of actual/suspected device.Method code #2: 11 - testing of device from same lot/batch retained by manufacturer.Method code #3: 3331 - analysis of production records.Results code: 213 - no device problem found.Conclusions code: 67 - no problem detected.Visual inspection was performed on the returned sample.Blood was noted in the umbrella valves.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 setup to be manually run through each of these tests to determine if the ops was functioning properly.The retention sample was visually inspected with no anomalies noted on the device.The sample was then manually run through the ops leak tests to ensure each component of the device is functioning as normal.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.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 ¿ and as indicated by terumo cardiovascular systems in the initial report submitted to the fda on october 26, 2020.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.

• Brand Name: VALVE, O.P.S BULK, N-S 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: 10737099
• MDR Text Key: 213193807
• Report Number: 1124841-2020-00242
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 12/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2022
• Device Model Number: LN130BJ
• Device Catalogue Number: N/A
• Device Lot Number: XP09
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/05/2020
• Initial Date FDA Received: 10/26/2020
• Supplement Dates Manufacturer Received: 11/02/2020; 12/08/2020
• Supplement Dates FDA Received: 11/23/2020; 12/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other