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

Model Number LN130B

Device Problem Infusion or Flow Problem (2964)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/02/2017

Event Type  malfunction  

Manufacturer Narrative

Visual inspection was performed on the returned sample, during which dried blood was visible within the valve.Upon evaluation of the returned sample, it was found to function as intended, and met all of the product specifications.Due to the timing of this event and the manufacture date of the valve, this is believed to be an issue with the forward flow through the duckbill valve.The reported issue was not able to be replicated; therefore, the complaint was not confirmed.The initial failure in negative pressure relief is likely due to dried blood around the negative umbrella valve, causing it to seal shut.Once the seal was broken and pressure was released, it was able to function as intended.There is a known issue currently ongoing with the duckbill valve within the ops valve, that prevents the duckbill from opening within the product specification range.The cause of the issue with the duckbill is due to a process change at the supplier, specifically during the washing/cleaning step; however, the (b)(4).All available information has been placed on file in quality management for appropriate tracking, trending and follow-up.

Event Description

The user facility reported to terumo cardiovascular that during cardiopulmonary bypass, the one way valve was not functioning properly.No consequences or impact to patient.Product was changed out.Procedure completed successfully.

Manufacturer Narrative

(b)(4).The investigation results and conclusions, previously reported, remain the same.

Event Description

(b)(4).

• 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
• Manufacturer Contact: cathleen hargreaves ; 125 blue ball road; elkton, MD 21921 ; 8002837866
• MDR Report Key: 6836034
• MDR Text Key: 85610201
• Report Number: 1124841-2017-00184
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 12/21/2017

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: 03/31/2020
• Device Model Number: LN130B
• Device Catalogue Number: N/A
• Device Lot Number: VF01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/11/2017
• Initial Date FDA Received: 08/31/2017
• Supplement Dates Manufacturer Received: 12/01/2017
• Supplement Dates FDA Received: 12/21/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 1124841-06/25/2017-001-C
• Patient Sequence Number: 1