MAUDE Adverse Event Report: EDWARDS LIFESCIENCES LLC CO-SET; CO-SET+CLOSED INJECTATE SYSTEM; FLOWMETER, BLOOD, CARDIOVASCULAR

Model Number 93610

Device Problem Break (1069)

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

Event Date 01/08/2016

Event Type  malfunction  

Event Description

Pa catheter injectate syringe broke off at hub.Staff states that this is the 3rd of its kind in the last 3 weeks to fail.

• Brand Name: CO-SET; CO-SET+CLOSED INJECTATE SYSTEM
• Type of Device: FLOWMETER, BLOOD, CARDIOVASCULAR
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC; one edwards way; irvine, CA 92614
• MDR Report Key: 5781741
• MDR Text Key: 49156449
• Report Number: 5781741
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/10/2016,06/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2016
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 93610
• Device Catalogue Number: 93610
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/10/2016
• Event Location: Hospital
• Date Report to Manufacturer: 05/10/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 70 YR