MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, LLC SYNCARDIA FREEDOM DRIVER; ARTIFICIAL HEART

Device Problem Output below Specifications (3004)

Patient Problem Fatigue (1849)

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 nair informed by rn of situation.Upon returned to pt room, dr (b)(6) was informed of the situation.Syncardia rep, (b)(6) also informed.Rep recommended switching c2 drivers at bedside.C2 driver (sn: (b)(4)) was connected to pt 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), dr (b)(6), dr (b)(6), dr (b)(6) decided to over pt to icu due to pt starting to get tired.Dr (b)(6) and dr (b)(6) were contacted by dr.(b)(6) for possible emergent surgery.Pt was transported to cv operating room:02 at 1840.(b)(6), syncardia rep called css to try to switch to another c2 driver before the pt undergoes surgery.Css staff informed dr.(b)(6) of syncardia recommendation and he agreed.C2 driver (sn: (b)(4)) connected to the pt in operating room.Pt's vital signs and syncardia parameters stabilized.

• Brand Name: SYNCARDIA FREEDOM DRIVER
• Type of Device: ARTIFICIAL HEART
• Manufacturer (Section D): SYNCARDIA SYSTEMS, LLC; tucson AZ 85713
• MDR Report Key: 6607452
• MDR Text Key: 76656774
• Report Number: MW5070139
• Device Sequence Number: 1
• Product Code: LOZ
• 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: 05/31/2017
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR
• Patient Weight: 89