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

Model Number CSS CONSOLE

Device Problems Device Contamination with Body Fluid (2317); Calibration Problem (2890); Device Operates Differently Than Expected (2913)

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

Event Date 07/22/2014

Event Type  malfunction  

Event Description

This css console was not supporting a pt.The css console had previously supported a pt at the hospital who was subsequently transplanted.The customer reported that the css console was unable to pass the console test validation protocol.He also reported that during calibration of the primary controller, the flow waveform looked unusual and the flow calibration numbers were inaccurate.The customer also reported that he observed what appeared to be blood in the drivelines, and he replaced them.This alleged failure mode posses a low risk to a pt because the issue was observed during a routine console checkout when the css console was not supporting a pt.In addition, it was not prevent the css console from performing its life-sustaining functions.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 DEVICE
• 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: 4213808
• MDR Text Key: 5153325
• Report Number: 3003761017-2014-00111
• 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: 08/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2014
• 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: 1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/22/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/01/2013
• 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