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

Model Number LN130BJ

Device Problem Use of Device Problem (1670)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/28/2015

Event Type  malfunction  

Manufacturer Narrative

Terumo has not received the actual 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/or when more information becomes available.No known impact or consequence to patient.Use of device issue.Conclusions: conclusion not yet available.

Event Description

The user facility reported to terumo cardiovascular systems that during cardiopulmonary bypass the user experienced "gradual and continuous air entrainment through the (ops) one-way valve." no known impact or consequence to the patient.The device was not changed out.The surgery was completed successfully without delay.

Manufacturer Narrative

This follow-up report is submitted to fda in accord with applicable regulations ¿ and as indicated by terumo cardiovascular system in the initial report submitted to the fda on (b)(6) 2015.(b)(4).Visual inspection was performed on the returned sample, during which no anomalies were noted anywhere 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 was manually run through each of these tests to determine if the umbrellas were functioning properly and not allowing air to enter the valve.No leaks occurred during any of the five tests, and the device met specifications.A review of the device history record revealed no indication of production related anomalies.The complaint was not confirmed.From the information received by the customer, the returned sample was not utilized in the vent line, as intended.A definitive root cause could not be determined, but the reported entrainment of air experienced is likely due to the use of the valve in the hemoconcentrator line and other unknown clinical conditions.(b)(4).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; 125 blue ball road; elkton MD 21921
• Manufacturer Contact: robyn o'donnell ; 125 blue ball road; elkton, MD 21921 ; 8002623304
• MDR Report Key: 5237989
• MDR Text Key: 31672804
• Report Number: 1124841-2015-00300
• 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,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/03/2015

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: 05/31/2018
• Device Model Number: LN130BJ
• Device Lot Number: TG08
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/02/2015
• Initial Date FDA Received: 11/19/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/03/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/12/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1