MAUDE Adverse Event Report: EDWARDS LIFESCIENCES LLC TRUWAVE, VAMP PLUS; TRANSDUCER, PRESSURE, CATHETER TIP

Model Number PXVP23X3

Patient Problems Tics/Tremor (4425); Embolism/Embolus (4438)

Event Date 08/20/2023

Event Type  malfunction  

Event Description

Rn was drawing blood sample utilizing vamp plus blood sampling system via brachial artery.Blood flow was slow when obtaining the clearing sample.Rn assessed line with no air noted.Rn then reinfused the clearing volume.Patient then experienced arm tremors with unresponsive episode.Stat ct head demonstrated left brain air embolus.Manufacturer response for transducer, pressure, catheter tip, truwave, vamp plus (per site reporter).Request for meeting to follow-up.

• Brand Name: TRUWAVE, VAMP PLUS
• Type of Device: TRANSDUCER, PRESSURE, CATHETER TIP
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC; one edwards way; irvine CA 92614
• MDR Report Key: 17876162
• MDR Text Key: 324993380
• Report Number: 17876162
• Device Sequence Number: 1
• Product Code: DXO
• 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: 08/28/2023

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: PXVP23X3
• Device Catalogue Number: PXVP23X3
• 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: 08/28/2023
• Device Age: 0 YR
• Event Location: Hospital
• Date Report to Manufacturer: 10/05/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/05/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 25185 DA
• Patient Sex: Male
• Patient Weight: 99 KG
• Patient Race: White