MAUDE Adverse Event Report: EDWARDS LIFESCIENCES LLC TRUWAVE VAMP PLUS 84IN 210CM; TRANSDUCER, PRESSURE, CATHETER TIP

Catalog Number PXVP2284

Patient Problems Air Embolism (1697); Bradycardia (1751); Cardiac Arrest (1762); Cyanosis (1798); Low Blood Pressure/ Hypotension (1914); Dizziness (2194); Cognitive Changes (2551); Ischemia Stroke (4418)

Event Date 08/28/2023

Event Type  malfunction  

Event Description

An icu patient was assisted out of bed into chair, then bedside commode, then back to chair by nursing staff.A left radial a-line was in place which was not accessed or manipulated while up.On transferring back to the chair, the patient complained of dizziness, became hypotensive, and had a change in mental status.An existing left forearm peripheral iv site was accessed, lactated ringers hung utilizing a pressure bag.The patient was lifted back to bed, became bradycardic with cyanosis from the neck up.Cpr began, patient intubated with rosc to a bradycardic pulse in 2 minutes.A central line was placed at rt groin, fluids infused via iv pump.A cardiac echo completed following cardiac arrest noted bubbles seen in the rt atrium and rt ventricle which do not cross to the left chambers.Mri brain reported multiple scattered areas of restricted diffusion in the supratentorial and infratentorial brain, most likely reflecting areas of acute ischemia/infarction.The patient remained in the icu, follows commands.

• Brand Name: TRUWAVE VAMP PLUS 84IN 210CM
• Type of Device: TRANSDUCER, PRESSURE, CATHETER TIP
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC; one edwards way; irvine CA 92614
• MDR Report Key: 17885264
• MDR Text Key: 325095461
• Report Number: 17885264
• 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: 09/02/2023

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 Catalogue Number: PXVP2284
• 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: 09/02/2023
• Device Age: 0 YR
• Event Location: Hospital
• Date Report to Manufacturer: 10/06/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/06/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 30660 DA
• Patient Sex: Male
• Patient Weight: 83 KG
• Patient Race: White