MAUDE Adverse Event Report: EDWARDS LIFESCIENCES, LLC CO-SET KIT; FLOWMETER, BLOOD, CARDIOVASCULAR

Model Number 93610

Device Problem Leak/Splash (1354)

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

Event Date 06/14/2019

Event Type  malfunction  

Event Description

Pt was transferred to icu post aortic valve replacement and coronary artery bypass graft x3 with placement of swan ganz catheter.When rn attempted to connect the co-set at the proximal end (the luer lock connection), there was leaking noted at the site of the luer lock.This required replacement of the entire co-set system.After co-set was changed there was no add'l leakage noted from the luer lock site.Pt tolerated the product exchange.Fda product safety report id# (b)(4).

• Brand Name: CO-SET KIT
• Type of Device: FLOWMETER, BLOOD, CARDIOVASCULAR
• Manufacturer (Section D): EDWARDS LIFESCIENCES, LLC; irvine CA 92614
• MDR Report Key: 8727355
• MDR Text Key: 149171479
• Report Number: MW5087557
• Device Sequence Number: 1
• Product Code: DPW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/07/2022
• Device Model Number: 93610
• Device Lot Number: 61821108 - NOT CONFIRMED
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2019
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 75 YR
• Patient Weight: 68