MAUDE Adverse Event Report: EDWARDS LIFESCIENCES AG EDWARDS CO-SET+; FLOWMETER, BLOOD, CARDIOVASCULAR

Model Number 93610

Device Problem Improper Flow or Infusion (2954)

Patient Problem No Information (3190)

Event Date 06/25/2014

Event Type  malfunction  

Event Description

Cardiac output flush tubing did not function properly.Tubing is designed to not backflow unless manual pressure is applied to the syringe to withdraw fluid.This was not working.Tubing and syringe were saved.

• Brand Name: EDWARDS CO-SET+
• Type of Device: FLOWMETER, BLOOD, CARDIOVASCULAR
• Manufacturer (Section D): EDWARDS LIFESCIENCES AG; one edwards way; irvine CA 92614
• MDR Report Key: 3994199
• MDR Text Key: 4820320
• Report Number: 3994199
• Device Sequence Number: 1
• Product Code: DPW
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 07/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Model Number: 93610
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/18/2014
• Event Location: Hospital
• Date Report to Manufacturer: 08/08/2014
• Patient Sequence Number: 1
• Patient Age: 64 YR