FDA Adverse Event Injury Summary report: N

SYNCARDIA SYSTEMS, LLC FREEDOM DRIVER

MDR report key: 6705831 · Received July 7, 2017

Report

Report Number
MW5070923
Event Type
Injury
Date Received
July 7, 2017
Date of Event
April 27, 2017
Report Date
July 7, 2017
Manufacturer
SYNCARDIA SYSTEMS, LLC
Product Code
LOZ
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
TX, US
Reporter Occupation
OTHER HEALTH CARE PROFESSIONAL

Narratives

Description of Event or Problem · 1

CSS STAFF NOTICED A DECREASE IN CARDIAC OUTPUT ON THE SYNCARDIA C2 DRIVER (SN: (B)(4)) IN THE CT SCAN WAITING AREA WHENEVER THE C2 DRIVER IS PLUGGED INTO WALL POWER AT AROUND 1700. CSS STAFF INFORMED (B)(6) RN ABOUT THE FINDINGS. DR. (B)(6) INFORMED BY RN OF SITUATION. DR. (B)(6) WAS INFORMED OF THE SITUATION. SYNCARDIA REP, (B)(6) ALSO INFORMED. REP RECOMMENDED SWITCHING C2 DRIVERS AT BEDSIDE. C2 DRIVER (SN: 10178) WAS CONNECTED TO PATIENT PER PROTOCOL UNDER THE SUPERVISION OF DR. (B)(6) AND WITNESSED BY (B)(6) RN AT 1800. LEFT CARDIAC OUTPUT AND LEFT FILL DECREASED TO AS LOW AS ZERO. DR. (B)(6) DECIDED TO MOVE PATIENT TO ICU DUE TO PATIENT STARTING TO GET TIRED. DR. (B)(6) WERE CONTACTED BY DR. (B)(6) FOR POSSIBLE EMERGENT SURGERY. PATIENT WAS TRANSPORTED TO CV OPERATING ROOM (OR): 02 AT 1840. (B)(6), SYNCARDIA REP CALLED CSS TO TRY TO SWITCH TO ANOTHER C2 DRIVER BEFORE THE PATIENT UNDERGOES SURGERY. CSS STAFF INFORMED DR. (B)(6) OF SYNCARDIA RECOMMENDATION AND HE AGREED. C2 DRIVER (SN: (B)(4)) CONNECTED TO THE PATIENT IN OPERATING ROOM. PATIENT'S VITAL SIGNS AND SYNCARDIA PARAMETERS STABILIZED.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
476288 SYNCARDIA SYSTEMS, LLC FREEDOM DRIVER FREEDOM DRIVER LOZ SYNCARDIA SYSTEMS, LLC
476289 SYNCARDIA SYSTEMS, LLC FREEDOM DRIVER FREEDOM DRIVER LOZ SYNCARDIA SYSTEMS, LLC

Patients

Seq Age Sex Outcome Treatment
1 59 YR Life Threatening