FDA Adverse Event Death Summary report: N

XVIVO HEART PRESERVATION SYSTEM

MDR report key: 19975628 · Received August 12, 2024

Report

Report Number
MW5158356
Event Type
Death
Date Received
August 12, 2024
Report Date
August 12, 2024
Manufacturer
XVIVO PERFUSION, INC.
Product Code
QIK
Report Source
Voluntary report
Reporter Occupation
PATIENT FAMILY MEMBER OR FRIEND
Health Professional
*

Narratives

Description of Event or Problem · 0

YES, I CALLED, AND I WAS TOLD TO SEND THESE PAPERS TO THE FDA. MY NAME IS (B)(6), WIFE OF (B)(6) WHO IS DECEASED. (B)(6) DIED ON (B)(6) 2024 FROM WHATEVER THIS IS THEY USED ON HIM. NO ONE EVER TALKED TO ME ABOUT THIS HEART TRANSPLANT, I NEVER SAW THESE PAPERS UNTIL THE OPERATION WAS OVER. GOT A TEXT MESSAGE AT 1:35AM IN THE MIDDLE OF THE NIGHT THAT IT WAS ALREADY STARTED. GOT ANOTHER ONE AROUND 8:45 THAT IT WAS OVER ON (B)(6). MY HUSBAND WAS NOT ABLE TO EVER READ WITHOUT GLASSES, THE GLASSES WERE AT HOME. HE HAD HAD 3 OR 4 CONGESTED HEART FAILURES SINCE 2019, HE HAD 2 BLOOD INFECTIONS, HE HAD A FOUR-HOUR OPERATION ON HIS LEFT EYE, HE HAD LEISURE SURGERY ON HIS RIGHT EYE, HE HAD BEEN AIR LIFTED TO (B)(6) BECAUSE HE HAD A MINISTROKE. HE HAD HAD TWO PACEMAKERS PUT IN; HE COULDN'T REMEMBER ONE DAY TO THE NEXT AT TIMES. HE WAS ON THE HEART LIST WHICH THEY SAID WOULD TAKE 3 TO 4 YEARS. HE WENT FOR A CHECK-UP, AND THEY TOLD HIM THAT THEY HAD FOUND SOMETHING WRONG, SO THEY KEPT HIM ON THE (B)(6) OF (B)(6). I KNEW NOTHING ABOUT A HEART TRANSPLANT THAT WAS GOING TO BE DONE ON THE (B)(6) OF (B)(6). HE WAS TURNED DOWN FOR A TRANSPLANT IN 2021 BECAUSE THERE WERE NOT ENOUGH FAMILY MEMBERS TO TAKE CARE OF HIM. HE DIED (B)(6) 2024.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1895751 XVIVO HEART PRESERVATION SYSTEM ORGAN CARE SYSTEM (OCS) HEART SYSTEM QIK XVIVO PERFUSION, INC.

Patients

Seq Age Sex Outcome Treatment
1 NA Unknown Death