MAUDE Adverse Event Report: EDWARDS LIFESCIENCES VAMP PLUS; VAMP PLUS KIT

Model Number	VAMPUNKNOWN
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Air/Gas in Device (4062)
Health Effect - Clinical Code	Air Embolism (1697)
Date of Event	08/28/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Edwards lifesciences was unable to perform due diligence efforts to retrieve the suspect device for analysis as there was no customer contact information provided in the voluntary incident report.No product was returned for evaluation, therefore, a definitive root cause could not be determined, and corrective or preventive action is not indicated at this time.The exact model and lot number are unknown.As the lot number is unknown, the device history record review could not be completed.An engineering evaluation has been initiated to assess for any manufacturing related processes which could be correlated to the complaint.
Event or Problem Description
Edwards lifesciences was notified via a direct voluntary incident report submission to the fda that a patient experienced air embolism issue.The voluntary incident report did not include customer contact information, patient information or product information related to the reported event.A truwave vamp plus device was involved.An icu patient was assisted out of bed into a chair, then to the bedside commode.Then assisted back to the chair by the nursing staff.A left radial arterial line was in place, which was not accessed or manipulated while the patient was up.On transferring the patient back to the chair, they complained of dizziness and became hypotensive and had a change in mental status.An existed left forearm peripheral iv site was accessed, lactated ringers hung utilizing a pressure bag.The patient was lifted back to bed and became bradycardic with cyanosis from the neck up.Cpr was begun and the patient was intubated with rosc to a bradycardic pulse in two minutes.A central line was placed at the right groin.Fluids were infused via an iv pump.A cardiac electrocardiogram was completed following cardiac arrest.There were noted bubbles seen in the right atrium and the right ventricle, which did not cross to the left chambers.An mri brain scan reported multiple scattered areas of restricted diffusion in the supra-tentorial and infratentorial brain.Most likely reflecting areas of acute ischemia/infarction.The patient remained in the icu, follows commands.
Additional Manufacturer Narrative
The subject complaint was opened in error as it is a duplicate.The initial report alleged that the edwards vamp plus contributed to air seen on imaging in the heart and brain.Upon follow-up with the facility, they determined that the air was introduced venously and not arterially and that the edwards vamp plus system was not involved with the patient injury.Therefore, the report of an adverse event is being retracted as the edwards device was ruled out as the cause.

• Brand Name: VAMP PLUS
• Common Device Name: VAMP PLUS KIT
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES DR; parque industrial de itabo; dominican republic; carr sanchez km 18.5
• Manufacturer Contact: katheryn cespedes ; 1 edwards way; irvine, CA 92614 ; 9492017706
• MDR Report Key: 21413012
• Report Number: 2015691-2025-01129
• Device Sequence Number: 8316909
• Product Code: KRA
• UDI-Device Identifier: 07460691955578
• UDI-Public: (01)07460691955578
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K896819
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/07/2025

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: VAMPUNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/27/2025
• Supplement Date Received by Manufacturer: 02/28/2025; 04/03/2025
• Initial Report FDA Received Date: 02/19/2025
• Supplement Report FDA Received Date: 03/13/2025; 04/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown