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

Device Problems Unintended Ejection (1234); Pumping Stopped (1503); Low Battery (2584); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/19/2017

Event Type  Injury  

Event Description

Patient did a freedom driver exchange at home around 1500, (b)(6) 2017.Patient stated that the reason for the freedom driver exchange was because the primary stopped working for about two seconds as he was changing out both batteries that were low.Initially, he took one low charged battery and replaced it with a full battery.The second low charged battery was ejected and the pump suddenly stopped for a couple of seconds so he immediately put back in the low charged battery into the freedom driver and it would not work until he physically tapped/hit on the freedom driver.He then did a freedom driver exchange.Patient stated that as he was doing the exchange, there was about 10 second pause due to fumbling with the equipment.Patient was told to come to the er by lvad coordinator, (b)(6).Backup freedom driver was set to 130 bpm, same as his primary freedom driver, and issued to patient at 1820.Patient looked stable.Bad freedom driver, sn: (b)(4), was collected and was sent to syncardia for evaluation.

• Brand Name: FREEDOM DRIVER
• Type of Device: ARTIFICIAL HEART
• Manufacturer (Section D): SYNCARDIA SYSTEMS, LLC; tucson AZ 85713
• MDR Report Key: 6701108
• MDR Text Key: 79770703
• Report Number: MW5070896
• 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

1 Device was Involved in the Event

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: 21 YR
• Patient Weight: 71