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 Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/21/2021

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.(b)(4).

Event Description

The user facility reported that during cardiopulmonary bypass, the aortic vent valve leaked at line 2.No known consequence or impact to patient.There was 10cc of blood loss.The product was not changed out.The procedure was completed successfully.

Manufacturer Narrative

Upon further investigation of the reported event.The following information is new and/or changed: d4: (additional device information, added expiration date); g3: (date received by manufacturer); g6: (indication that this is a follow-up report); h2: (follow-up, due to additional information); h4: (device manufacture date); h6: (identification of evaluation codes 11, 3331, 4114, 3221, 4315).Type of investigation: #1: 11, testing of device from same lot/batch retained by manufacturer.Type of investigation #2: 3331, analysis of production records.Type of investigation #3: 4114, device not returned.Investigation findings: 3221, no findings available.Investigation conclusions: 4315, cause not established.The complaint sample was not returned for a thorough investigation.And a definitive root cause could not be determined.Upon evaluation of the retention sample with no anomalies.Noted on the device, it was found, to function as intended, and met all of the product specifications.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.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: 12154847
• MDR Text Key: 261539216
• Report Number: 1124841-2021-00165
• 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,distri
• Type of Report: Initial,Followup
• Report Date: 08/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 01/31/2024
• Device Model Number: LN130B
• Device Catalogue Number: N/A
• Device Lot Number: ZC22
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1