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

Model Number LN130B

Device Problem Leak/Splash (1354)

Patient Problems Injury (2348); Blood Loss (2597)

Event Date 02/24/2020

Event Type  Injury  

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 Description

The user facility reported to terumo cardiovascular that during cardiopulmonary bypass, the valve leaks blood with every heartbeat.Per user facility, the patient had a vent valve issue.From the time the clamp came off until they made the decision to cool and go back was only about 20 minutes.After clamp came off and while the heart was beating.With every heartbeat, a little bit of blood leaks out.During that time the average patient arterial line pressure was 67mmhg.The highest systolic pressure, when they filled to let the heart eject and assess on echo, was 111mmhg (map 86mmhg at that time).The valve had already failed by then and they were switching it out so they could apply the cross clamp again.The vent valve was used in aortic root vent line.There was 3-5cc of blood loss.The product was changed out.The surgery 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 march 18, 2020.Upon further investigation of the reported event, the following information is new and/or changed: d4 (additional device information - added expiration date) g4 (date received by manufacturer) g7 (indication that this is a follow-up report) h2 (follow-up due to additional information and device evaluation) h3 (device evaluated by manufacturer) h4 (device manufacture date) 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.There was blood noted within the valve, no other visual anomalies were noted on the sample.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 umbrellas were functioning properly and not allowing air to enter the valve.The returned sample met specification and functioned as intended.The retention sample was functioned as intended.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
• Type of Device: OVERPRESSURE SAFETY VALVE
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; 125 blue ball road; elkton MD 21921
• MDR Report Key: 9849519
• MDR Text Key: 188530555
• Report Number: 1124841-2020-00072
• 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,health
• Type of Report: Initial,Followup
• Report Date: 04/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2021
• Device Model Number: LN130B
• Device Catalogue Number: N/A
• Device Lot Number: WK06
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 152 MO
• Patient Weight: 52