MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, LLC SYNCARDIA SYSTEMS, LLC FREEDOM DRIVER

Device Problem Device Operational Issue (2914)

Patient Problems Fatigue (1849); Low Cardiac Output (2501)

Event Date 04/27/2017

Event Type  Injury  

Event Description

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.

• Brand Name: SYNCARDIA SYSTEMS, LLC FREEDOM DRIVER
• Type of Device: FREEDOM DRIVER
• Manufacturer (Section D): SYNCARDIA SYSTEMS, LLC; tucson AZ 85713
• MDR Report Key: 6705831
• MDR Text Key: 79938957
• Report Number: MW5070923
• Device Sequence Number: 1
• Product Code: LOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/07/2017
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 59 YR
• Patient Weight: 83