FDA Adverse Event Death Summary report: N

JARVIK 2000

MDR report key: 6512534 · Received April 12, 2017

Report

Report Number
6512534
Event Type
Death
Date Received
April 12, 2017
Date of Event
January 25, 2017
Report Date
April 7, 2017
Manufacturer
JARVIK HEART, INC
Product Code
DSQ
Report Source
User Facility report
Reporter Location
NY, US
Reporter Occupation
OTHER

Narratives

Description of Event or Problem · 1

PATIENT HAD JARVIK 2000 VAD PLACED IN 2013. HE WAS ADMITTED ON (B)(6) 2017 WITH FATIGUE, COUGH AND 2 MECHANICAL FALLS, FATIGUE AND QUESTIONABLE PUMP STOPPAGES. ON THE DAY OF ADMISSION THE NURSE HEARD THE LVAD ALARM AND FOUND THE PATIENT UNRESPONSIVE. THE CONTROLLER AND PEDESTAL WIRES WERE CHANGED AND THE PATIENT RESUSCITATED. DURING THE SECOND INCIDENT, THE NURSE RESPONDED TO THE LVAD ALARM AND FOUND THE PATIENT DISCONNECTED FROM THE CONTROLLER. HE IMMEDIATELY WAS RECONNECTED AND REGAINED CONSCIOUSNESS. IT APPEARED THE PATIENT DISCONNECTED THE DEVICE. HE WAS EVALUATED BY PSYCHIATRY, DEEMED TO HAVE MILD TO MODERATE DEMENTIA BUT NOT DEEMED TO BE SUICIDAL. DURING THE 3RD INCIDENT, THE NURSE WAS NOTIFIED BY TELEMETRY THAT THE PATIENT WAS IN VENTRICULAR FIBRILLATION/TACHYCARDIA VF/VT). SHE IMMEDIATELY WENT INTO THE ROOM AND FOUND THE PATIENT IN A CHAIR UNRESPONSIVE, APNEIC, AND PULSELESS. THE LVAD BATTERY WAS DISCONNECTED BUT REPORTEDLY NO ALARMING. HE WAS RECONNECTED, BUT DID NOT RESPOND AND WAS PRONOUNCED DECEASED. FOLLOW-UP TESTING ON THE EQUIPMENT BY HOSPITAL'S BIOMED DEPARTMENT AND THE MFR FOUND NO EVIDENCE OF EQUIPMENT MALFUNCTION.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
270136 JARVIK 2000 JARVIK VAD DSQ JARVIK HEART, INC 2000

Patients

Seq Age Sex Outcome Treatment
1 81 YR Death