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 Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/01/2021

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.For this reason.(b)(4).

Event Description

The user facility reported to terumo cardiovascular that during cardiopulmonary bypass, the one way valve in the red sucker leaked blood.It is unknown whether the product was changed out, or if there was any effect on the patient or results of the surgery.Terumo continues to attempt to gain more information regarding this event from the user facility.

Event Description

Additional information received indicates that, there was no delay in the procedure, and the surgery was completed successfully with a minimal blood loss.The product was not changed out; the valve was cut out on bypass to minimise the impact so no harm caused.

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 july 20, 2021.  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).H6 (adverse event problem 2199, 4582, 11).A second follow-up will be submitted upon completion of the investigation and/or submission of new information, thus tcvs references conclusions code 11.) all available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.

Event Description

New information received, that the red sucker line is the aortic root vent line.As it was confirmed, by the user facility.

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: b5: (updated describe event or problem).D4: (additional device information, added exp date).G3: (date received by manufacturer).G6: (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, 3331, 213, 67).Type of investigation #1: 10, testing of actual/suspected device.Type of investigation #2: 3331, analysis of production records.Investigation findings: 213, no device problem found.Investigation conclusions: 67, no problem detected.The returned 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 returned sample passed the leak testing.The evaluation of the returned 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 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: 12195267
• MDR Text Key: 264279369
• Report Number: 1124841-2021-00173
• 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: 08/27/2021

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: 12/31/2022
• Device Model Number: LN130B
• Device Catalogue Number: N/A
• Device Lot Number: YA27
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/01/2021
• Initial Date FDA Received: 07/20/2021
• Supplement Dates Manufacturer Received: 07/20/2021; 08/12/2021
• Supplement Dates FDA Received: 08/06/2021; 08/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1