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

Model Number 831F75

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem Insufficient Information (4580)

Event Date 06/08/2021

Event Type  malfunction  

Event Description

Patient with ef 55% has cabg (coronary artery bypass graft) done by a doctor.The patient core temperature registered as 37.8 c upon arrival, then dropped to 32c.The nurse checked the axillary temperature was 35.5 c, she changed another co cable, the doctor witnessed the core temperature kept changing range from 31 to 36.5 c within minutes and could not stay constant for short period of time.The ci was 1.01, svr > 2200, pa wave form normal with 33/15 mmhg, then the doctor called for a mixed venous saturation which was 68%.The nurse stopped the epinephrine gtt (drops).The doctor communicated with another doctor about the unreliable ci and asked the nurse to save the catheter for the vendor.

• Brand Name: SWAN-GANZ VIP
• Type of Device: CATHETER, FLOW DIRECTED
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC; one edwards way; irvine CA 92614
• MDR Report Key: 11990701
• MDR Text Key: 255943470
• Report Number: 11990701
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/11/2021,06/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 831F75
• Device Catalogue Number: 831F75P
• Device Lot Number: 63462939
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/11/2021
• Device Age: 1 MO
• Event Location: Hospital
• Date Report to Manufacturer: 06/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 28470 DA
• Patient Weight: 96