MAUDE Adverse Event Report: SYNCARDIA TOTAL ARTIFICIAL HEART CPC CONNECTOR; ARTIFICIAL HEART

Model Number 50CC

Device Problems Device Maintenance Issue (1379); Connection Problem (2900); Device Misassembled During Manufacturing /Shipping (2912)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/20/2017

Event Type  Injury  

Event Description

(b)(6) staff changed patient freedom driver to back up freedom driver because the primary was due for maintenance.Css staff encountered a problem with the cpc connectors that required (b)(6) to take off the entire connector from the tubing in order to change the driver.(b)(6) proceeded with the procedure despite the manufacturing error, in which resulted in a safe switch.The patient is feeling normal and the machine is functioning properly.

• Brand Name: CPC CONNECTOR
• Type of Device: ARTIFICIAL HEART
• Manufacturer (Section D): SYNCARDIA TOTAL ARTIFICIAL HEART; tuscon AZ 85713
• MDR Report Key: 7052403
• MDR Text Key: 92862394
• Report Number: MW5073520
• 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
• Type of Report: Initial
• Report Date: 11/20/2017

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: Lay User/Patient
• Device Model Number: 50CC
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/22/2017
• 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: 56 YR
• Patient Weight: 82