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

Model Number LH130

Device Problem Leak/Splash (1354)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/23/2023

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.For this reason, terumo references evaluation conclusion code 11.Component code: 527 - valve(s) health effect - impact code: 2199 - no health consequences or impact heatlh effect - clinical code: 4582 - no clinical signs, symptoms or conditions medical device problem code: 1354 - leak/splash.Investigation findings: 3233 - results pending completion of investigation investigation conclusions: 11 - conclusion not yet available.

Event Description

The user facility reported to terumo cardiovascular that during cardiopulmonary bypass, they noticed a leaked valve.As per user facility, the first valve used was a vrv-ii line a18 pack 75563-01, leaked 15mins post cardioplegia, after the vent was turned on, and they lost 15cc of blood; therefore, they changed it out with the ops valve which also leaked 5 ml of blood.They changed it out again with the same product to complete the case.*there was a known delay in the procedure *product was changed out *procedure completed successfully with 5ml blood loss.

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 16, 2023.Upon further investigation of the reported event, the following information is new and/or changed: g6 (indication that this is a follow-up report).H2 (follow-up due to additional information and device evaluation).H6 (identification of evaluation codes 10, 11, 3331, 213, 4307).Type of investigation #1: 10 - testing of actual/suspected device.Type of investigation #2: 11 - testing of device from same lot/batch retained by manufacturer.Type of investigation #3: 3331 - analysis of production records.Investigation findings: 213 - no device problem found.Investigation conclusions: 4307 - cause traced to component failure.The affected sample was visually inspected with no anomalies 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 affected sample and a previously tested representative retention sample passed the tests with no leaks noted.The evaluation of the complaints' sample was found to function as intended and met all of the product specifications.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)
• Type of Device: OVERPRESSURE SAFETY VALVE
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; 125 blue ball road; elkton MD 21921
• Manufacturer (Section G): SAME
• Manufacturer Contact: jamie quinlan ; 125 blue ball road; elkton, MD 21921 ; 8002837866
• MDR Report Key: 16554327
• MDR Text Key: 311780514
• Report Number: 1124841-2023-00070
• Device Sequence Number: 1
• Product Code: DTL
• UDI-Device Identifier: 00699753450226
• UDI-Public: (01)00699753450226
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K820297
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/18/2023

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
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2024
• Device Model Number: LH130
• Device Catalogue Number: N/A
• Device Lot Number: ZE05
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/23/2023
• Initial Date FDA Received: 03/16/2023
• Supplement Dates Manufacturer Received: 03/30/2023
• Supplement Dates FDA Received: 04/18/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/07/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1