FDA Adverse Event Death Summary report: N

DV ASST RT PMP

MDR report key: 11747677 · Received April 29, 2021

Report

Report Number
11747677
Event Type
Death
Date Received
April 29, 2021
Date of Event
January 19, 2020
Report Date
January 29, 2020
Manufacturer
HEARTWARE
Product Code
DSQ
Adverse Event
Yes
Product Problem
Yes
Report Source
User Facility report
Reporter Location
FL, US
Reporter Occupation
OTHER

Narratives

Description of Event or Problem · 1

PATIENT WITH CARDIAC DIAGNOSES OF DILATED CARDIOMYOPATHY, VENTRICULAR TACHYCARDIA, S/P V-FIB CARDIAC ARREST (B)(6) 2019; S/P BI-VAD HEARTWARE IMPLANTATION (B)(6) 2019; LISTED FOR HEART TRANSPLANT ON (B)(6) WAITLIST AS STATUS 1A ON (B)(6) 2019, ON (B)(6) 2020 LVAD TEAM RECEIVED A PHONE CALL FROM THE PATIENT'S MOTHER STATING THE PATIENT'S LVAD HAD STOPPED WORKING. NURSE PRACTITIONER THAT WAS SPEAKING WITH THE MOTHER HAD GONE THROUGH THE ALGORITHM OF CHANGING OUT BATTERIES, SWAPPING CONTROLLERS WITH RVAD AND OTHER MEASURES. NURSE PRACTITIONER HAD BEEN IN CONTACT WITH (B)(6), FROM HEARTWARE, PER NURSE PRACTITIONER'S NOTES, THE LVAD WAS ALARMING THAT THE VAD STOPPED WITH A SECONDARY MESSAGE TO CHANGE THE CONTROLLER, NURSE PRACTITIONER INSTRUCTED FAMILY TO CALL RESCUE WHICH WAS DONE, INTERVENTIONS WERE UNSUCCESSFUL TO RESTART LVAD. RESCUE ARRIVED AND TOOK THE PATIENT TO THE HOSPITAL WHERE HE WAS PRONOUNCED DEAD. PER NOTES, THE PATIENT HAD A THERAPEUTIC INR ON (B)(6) 2020. THE EQUIPMENT PLACED ON (B)(6) 2019 ALONG WITH LVAD/RVAD WERE GFT VASC 10 MM; MODEL/CATH 1125; LOT# 17407768-1286; EXP DATE 01/31/2023 TO LEFT AND RIGHT.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
640348 DV ASST RT PMP LVAD/RVAD DSQ HEARTWARE 1103

Patients

Seq Age Sex Outcome Treatment
1 17 YR Death