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 07/07/2021

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 to terumo cardiovascular that the vent was leaking.It is unknown when this event occurred, whether the surgery was completed successfully or whether 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.The product was changed out.

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 23, 2021.Upon further investigation of the reported event, the following information is new and/or changed: b5 (added describe event or problem).G3 (date received by manufacturer).G6 (indication that this is a follow-up report).H2 (follow-up due to additional information).H6 (identification of evaluation codes 2199, 4582).Health effect - impact code: 2199 - no health consequences or impact.Health effect - clinical code: 4582 - no clinical signs, symptoms or conditions.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 was received indicating that the event occurred during cardiopulmonary bypass, the surgery was completed successfully, there was no delay in the procedure and there was 50 ml blood loss.

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: 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.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: 12218950
• MDR Text Key: 264322657
• Report Number: 1124841-2021-00177
• 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,Followup
• Report Date: 08/31/2021

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: 01/31/2024
• Device Model Number: LN130B
• Device Catalogue Number: N/A
• Device Lot Number: ZC08
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/07/2021
• Initial Date FDA Received: 07/23/2021
• Supplement Dates Manufacturer Received: 07/26/2021; 08/26/2021
• Supplement Dates FDA Received: 08/10/2021; 08/31/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1