MAUDE Adverse Event Report: SYNCARDIA SYSTEMS SYNCARDIA COMPANION HOSPITAL CART TAH DEVICE

Model Number 10A 250V

Device Problem Disconnection (1171)

Patient Problem No Information (3190)

Event Date 08/04/2014

Event Type  Injury  

Event Description

The pt's total artificial heart machine tube disconnected at the connector point on the driveline.Dates of use: (b)(6) 2014.Event reappeared after reintroduction: no.

• Brand Name: SYNCARDIA COMPANION HOSPITAL CART TAH DEVICE
• Type of Device: TAH DEVICE
• Manufacturer (Section D): SYNCARDIA SYSTEMS; tucson 85713
• MDR Report Key: 4046830
• MDR Text Key: 4808065
• Report Number: MW5037929
• 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: Nurse
• Type of Report: Initial
• Report Date: 08/21/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10A 250V
• Device Lot Number: T300000003853
• Other Device ID Number: 397003-001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/22/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR
• Patient Weight: 60