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

Model Number CSS CONSOLE

Device Problem Loose or Intermittent Connection (1371)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/06/2014

Event Type  malfunction  

Event Description

The customer reported that the power cord on the css console would come loose, causing the css console to switch to battery power.There was no patient impact.The patient was subsequently switched to a backup css console.This alleged failure mode poses low risk to the patient because it did not prevent the css console from performing its life-sustaining functions.The css console will be returned to syncardia for evaluation.The results of the investigation will be provided in a supplemental mdr.

Manufacturer Narrative

(b)(4).Please note the initial mdr reported that the patient was subsequently switched to a back up css console.This has been corrected to "the power cord was replaced with a hospital stock power cord." power cord was not returned to syncardia.

Event Description

The customer reported that the power cord on the css console would come loose, causing the css console to switch to battery power.The customer also reported that the power cord was replaced with a hospital stock power cord.There was no patient impact.The css console functioned as intended by switching to battery power when the ac power cord connection was loose.The original suspected loose power cord was never returned to syncardia for investigation.Prior to shipment, syncardia performs an electrical safety inspection on the css console, and the results are recorded on form 901105-000.Css console # 13 met all acceptable criteria for electrical safety.The ac power cord connection was verified to fit with the power cord receptacle and to function properly per (b)(4), tah-t console final production/verification checklist.Css console # 13 was returned to syncardia on 19 dec 2014 for regularly scheduled 2 year service.There were no other reported issues regarding the css console # 13 between 06 oct 2014 and 19 dec 2014.The css console was serviced and passed all final performance testing prior to being placed into finished goods.This alleged failure mode poses a low risk to the patient because it did not prevent the css console from performing its life-sustaining functions.The css console has redundant, alternate power source of batteries.This issue will continue to be monitored and trended as part of the customer experience process.Syncardia has completed its evaluation of this complaint and is closing this file.

• Brand Name: SYNCARDIA CIRCULATORY SUPPORT SYSTEM CONSOLE
• Type of Device: CSS CONSOLE
• Manufacturer (Section D): SYNCARDIA SYSTEMS, INC.; 1992 e. silverlake road; tucson AZ 85713
• Manufacturer (Section G): SYNCARDIA SYSTEMS, INC.; 1992 e. silverlake road; tucson AZ 85713
• Manufacturer Contact: carole marcot ; 1992 e. silverlake road; tucson, AZ 85713 ; 5205451234
• MDR Report Key: 4212581
• MDR Text Key: 5152784
• Report Number: 3003761017-2014-00221
• 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,health professional,use
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 10/06/2014

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: Other Health Care Professional
• Device Model Number: CSS CONSOLE
• Device Catalogue Number: 400207
• Device Lot Number: 13
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/06/2014
• Initial Date FDA Received: 10/24/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/01/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 49 YR