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

Model Number PXVPL2284

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Event Date 03/05/2023

Event Type  Injury  

Event Description

During use of vesicle associated membrane protein (vamp) system, an arterial blood gas was drawn.After flushing the device to clear the volume the patient had a change in mental status.Patient became unresponsive, not responding to verbal or noxious stimuli, and not moving extremities.Acute stroke team was called.Brain imaging notable for pneumocephalus in right parieto-occipital region.Manufacturer response for transducer, pressure, catheter tip, truwave, vamp plus (per site reporter).Manufacturer is completing internal testing to test system.

• 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: 16609724
• MDR Text Key: 311949752
• Report Number: 16609724
• Device Sequence Number: 1
• Product Code: DXO
• UDI-Device Identifier: 00690103200348
• UDI-Public: (01)00690103200348
• 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: 03/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: PXVPL2284
• Device Catalogue Number: PXVPL2284
• Device Lot Number: 64598033
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/17/2023
• Device Age: 0 YR
• Event Location: Hospital
• Date Report to Manufacturer: 03/24/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/24/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Disability; Hospitalization
• Patient Age: 11315 DA
• Patient Sex: Male
• Patient Weight: 98 KG
• Patient Race: White