MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, INC. SYNCARDIA CIRCULATORY SUPPORT SYSTEM CONSOLE; CIRCULATORY ASSIST DRIVE

Model Number CSS CONSOLE

Device Problem Image Display Error/Artifact (1304)

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

Event Date 08/27/2014

Event Type  malfunction  

Event Description

This css console was not supporting a patient.The customer reported that during a routine console checkout, the css console monitoring computer displayed incorrect hemodynamic information when the primary controller was operating and the battery test pushbutton on the backup controller was pressed.The customer also reported that this issue occurred intermittently when the battery test pushbutton on the backup controller was pushed.This alleged failure mode poses a low risk to a patient because it was observed during a routine console checkout when the css console was not supporting a patient.In addition, this alleged failure mode would not prevent the css console form performing its life-sustaining functions.The computer is a monitoring device only and does not control css console functionality.An investigation will be conducted by syncardia.The results of the investigation will be provided in a supplemental mdr.

• Brand Name: SYNCARDIA CIRCULATORY SUPPORT SYSTEM CONSOLE
• Type of Device: CIRCULATORY ASSIST DRIVE
• Manufacturer (Section D): SYNCARDIA SYSTEMS, INC.; tucson AZ
• Manufacturer Contact: carole marcot, esq. vp ; 1992 e. silverlake rd.; tucson, AZ 85713 ; 5205451234
• MDR Report Key: 4214743
• MDR Text Key: 17574904
• Report Number: 3003761017-2014-00164
• Device Sequence Number: 1
• Product Code: LOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/27/2014

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: CSS CONSOLE
• Device Catalogue Number: 400207
• Device Lot Number: 23
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/27/2014
• Initial Date FDA Received: 09/25/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/01/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1