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

Model Number 777F8

Device Problem Protective Measures Problem (3015)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/11/2021

Event Type  malfunction  

Event Description

Elderly male with history of hypertension, coronary artery disease and chronic heart failure.Procedure coronary artery bypass graft x 2 and mitral valve repair.Continuous cardiac output swan ganz catheter not working appropriately.Getting a check thermal filament connection error.Multiple cables were tried.Error occurred with continuous cardiac output monitor in both cardiovascular or and cardiovascular icu.Discussed with surgeon and decision not to replace as he is okay with pa pressures and does not need cardiac index/output.

• Brand Name: SWAN-GANZ CCOMBO V
• Type of Device: CATHETER, OXIMETER, FIBEROPTIC
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC; one edwards way; irvine CA 92614
• MDR Report Key: 11504034
• MDR Text Key: 240341688
• Report Number: 11504034
• Device Sequence Number: 1
• Product Code: DQE
• UDI-Device Identifier: 00690103146554
• UDI-Public: (01)00690103146554(17)221028(11)201028(10)63449712
• 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: 03/15/2021

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 Model Number: 777F8
• Device Catalogue Number: 777F8
• Device Lot Number: 63449712
• 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: 03/15/2021
• Event Location: Hospital
• Date Report to Manufacturer: 03/17/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/17/2021
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 27010 DA
• Patient Weight: 85