FDA Adverse Event Death Summary report: N

VRV100

MDR report key: 10309393 · Received July 20, 2020

Report

Report Number
10309393
Event Type
Death
Date Received
July 20, 2020
Date of Event
July 8, 2020
Report Date
July 14, 2020
Manufacturer
MEDTRONIC
Product Code
DWE
Adverse Event
Yes
Product Problem
Yes
Report Source
User Facility report
Reporter Location
FL, US
Reporter Occupation
NURSE

Narratives

Description of Event or Problem · 1

ON (B)(6) 2020 THIS PATIENT WAS SCHEDULED AT (B)(6) FOR SURGERY TO HAVE HIS MITRAL VALVE REPAIR WITH TRICUSPID VALVE REPAIR. HE ARRIVED AT 05:30 AM TO BE PRE-OP FOR HIS PROCEDURE. PRE-OP WAS WITHOUT INCIDENT. PATIENT WAS BROUGHT INTO THE OPERATING ROOM AT 07:45 TO CONDUCT THE ANESTHESIA TIME OUT. AT 09:09, SURGERY WAS STARTED AFTER OUR SURGICAL TIME OUT WAS COMPLETE. BEGINNING OF THE SURGERY WAS WITHOUT INCIDENT UNTIL SURGEON NOTED AIR IN THE Y TUBING OF THE PERFUSIONIST SYSTEM DELIVERING THE CARDIOPLEGIA. AS SOON AS NOTICED BYPASS WAS TURNED OFF AND PATIENT WAS PUT INTO TRENDELENBURG TO REMOVE THE AIR. ONCE AIR REMOVED, PATIENT WAS RETURNED TO BYPASS AND CONTINUED DELIVERY OF THE CARDIOPLEGIA. ONCE THE PATIENT'S HEART WAS APPROPRIATELY ARRESTED, SURGEON COULD BEGIN BYPASS SURGERY. MOMENTS LATER, THE PERFUSIONIST NOTICED DROPLETS OF BLOOD ON THE FLOOR UNDER HER EQUIPMENT. SHE IMMEDIATELY INVESTIGATED AND NOTICED IT DRIPPING FROM A ONE WAY VALVE ON THE BYPASS EQUIPMENT. SHE CONFIRMED WITH SURGEON WHEN WAS A SAFE TIME TO REPLACE AND VALVE WAS REMOVED AND NEW ONE IN ITS PLACE. BLOOD DROPLETS NO LONGER HAPPENING. SURGERY CONTINUED FOR ANOTHER HOUR OR SO. WHEN THE TEAM WENT TO COME OFF BYPASS THE PATIENT'S HEART DID NOT MOVE. BY 10AM OPERATING ROOM TEAM WORKED TO GET THE PATIENT'S HEART TO MOVE. THEY PUT THE PATIENT ON ECMO AND USED CRYOMAZE PROCEDURE. THIS PATIENT REMAINED IN THE OPERATING ROOM UNTIL 20:35 WHEN HE WAS TRANSFERRED TO ICU IN CRITICAL CONDITION. HIS HEART EXPERIENCED POST BYPASS SHOCK. THE FOLLOWING MORNING, SURGEON TOOK PATIENT BACK TO OPERATING ROOM TO EXPLORE THE STERNUM. PATIENT WAS MADE A DNR BY HUSBAND NIGHT PRIOR. ONCE IN OPERATING ROOM NEXT MORNING, MEDIASTINAL WAS WASHOUT, THEY REMOVED EMCO - WITH NO MOVEMENT OF THE HEART. PUPILS WERE DILATED AND FIXED. TIME OF DEATH WAS CALLED AT 10:30 DUE TO DNR AND FUTILITY IN TREATMENT.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
757950 VRV100 ONE WAY VALVE (PART OF A PUMP BACK FOR BYPASS SURGERY) DWE MEDTRONIC VRV100 219291058

Patients

Seq Age Sex Outcome Treatment
1 69 YR Death