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

Model Number LN130B

Device Problem Leak/Splash (1354)

Patient Problem Blood Loss (2597)

Event Date 03/16/2017

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.(b)(4).Results: results pending completion of evaluation.Conclusions: conclusion not yet available-evaluation in progress.

Event Description

The user facility reported to terumo cardiovascular that during cardiopulmonary bypass, the vent valve leaked.Product was not changed out.Blood loss of 10ml.Procedure completed successfully.

Manufacturer Narrative

All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.

Manufacturer Narrative

This follow-up report is submitted to the fda in accord with applicable regulations - and as indicated by terumo cardiovascular system in the initial report submitted.Method: actual device evaluated.Device from reserve sample evaluated.Visual inspection.Manufacturing review.Pressure testing.Results: improper physical structure.Conclusions: human factors issue.Visual inspection was performed on the returned sample, during which no anomalies were noted.A review of the device history record revealed no manufacturing anomalies.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 following test was performed: program 1: the sample was connected in a circular circuit and pressurized with a syringe to 3.5psi while submerged under water to test the body of the ops for leaks.A leak was seen from the positive umbrella, and the valve was not able to hold pressure.A retention sample from the same product code/lot number combination was obtained.Visual inspection found no anomalies on the retention sample.It was then manually run through each of the five leak tests to determine if the umbrellas were functioning properly.The retention sample was found to pass all five leak tests.All units are also 100% visually inspected both during the leak testing step and during packaging.It is possible that the unit was subjected to damage at some point after final release causing the positive umbrella to not be seated properly, or to release at a much lower pressure than 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 CORP.; 125 blue ball road; elkton MD 21921
• Manufacturer Contact: cathleen hargreaves ; 125 blue ball road; elkton, MD 21921 ; 8002837866
• MDR Report Key: 6463502
• MDR Text Key: 72336111
• Report Number: 1124841-2017-00052
• Device Sequence Number: 1
• Product Code: DTL
• 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: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/11/2017

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: 12/31/2019
• Device Model Number: LN130B
• Device Catalogue Number: N/A
• Device Lot Number: VA09
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/16/2017
• Initial Date FDA Received: 04/06/2017
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 04/27/2017; 05/11/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/09/2017
• 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