MAUDE Adverse Event Report: EDWARDS LIFESCIENCES LLC SWAN-GANZ CCOMBO V; CATHETER, FLOW DIRECTED

Model Number 777F8

Device Problem Capturing Problem (2891)

Patient Problem Insufficient Information (4580)

Event Date 03/02/2023

Event Type  malfunction  

Event Description

Patient had pa line placed in or.Pa line unable to capture co and ci.The provider changed the edwards cco monitor and cable twice.Determined it was an error with the pa line.Pa line was removed and a new one placed.The case proceeded as planned.

• Brand Name: SWAN-GANZ CCOMBO V
• Type of Device: CATHETER, FLOW DIRECTED
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC; one edwards way; irvine CA 92614
• MDR Report Key: 16582473
• MDR Text Key: 311683359
• Report Number: 16582473
• Device Sequence Number: 1
• Product Code: DYG
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 777F8
• Device Catalogue Number: 777F8
• Device Lot Number: 777F8
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/07/2023
• Event Location: Hospital
• Date Report to Manufacturer: 03/21/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 26280 DA
• Patient Sex: Male
• Patient Weight: 88 KG
• Patient Race: White