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

Device Problems Device Operates Differently Than Expected (2913); Material Protrusion/Extrusion (2979)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/15/2015

Event Type  malfunction  

Event Description

Patient intubated on intra-aortic balloon pump (iabp), ino2 and continual renal replacement therapy (crrt) status post emergent open heart surgery and cardiogenic shock; swan was in use - rn noticed numbers fluctuating, swan ganz was inspected and rn noticed two wires sticking outside the white cable connection.This was first noticed earlier in the month but doctors decided not to exchage swan ganz due to patient's unstable conditions.Patient weaned off inos three days later and remains on iabp, crrt and guttae.There was no harm to the patient.Per icu manager.We calculated fick cardiac output and the numbers correlated with swan numbers.It may be an issue - wires outside- in the future though, manufacturer should know that this product wasn't 100%.

• Brand Name: SWAN-GANZ
• Type of Device: CATHETER, OXIMETER, FIBEROPTIC
• Manufacturer (Section D): EDWARDS LIFESCIENCES, LLC.; one edwards way; irvine CA 92614
• MDR Report Key: 4591871
• MDR Text Key: 5449117
• Report Number: 4591871
• Device Sequence Number: 1
• Product Code: DQE
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 02/26/2015

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: Invalid Data
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/26/2015
• Event Location: Hospital
• Date Report to Manufacturer: 03/11/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/26/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 58 YR