MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, INC. SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART

Model Number TAH-T

Device Problem Connection Problem (2900)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/04/2014

Event Type  Injury  

Event Description

Syncardia is filling this mdr in response to an mdr filed by (b)(6) med ctr regarding an alleged disconnect of a pt's tah-t cannula from the companion 2 driver driveline (reported as "syncardia companion hosp cart tah device").Syncardia was not notified of the reported event by the hospital staff.Syncardia conducted an investigation by having a syncardia clinical support specialist contact the clinical staff at (b)(6) med ctr.The syncardia clinical support specialist spoke to the icu nurse who remembered the reported event.The pt was in the icu.The nurse was trying to stand the pt up and the cannulae/drivelines "got caught on something," causing a disconnect.The cannulae/drivelines were reconnected.There was no reported pt impact.

Manufacturer Narrative

Syncardia was also advised that the pt had no other issues with his cannulae or drivelines.He was successfully transplanted on (b)(6) 2015.The hosp did not return the tah-t cannulate, driver drivelines or connectors to syncardia; therefore, no eval can be conducted by syncardia.Syncardia has completed its eval of this issue and is closing this file.

• Brand Name: SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART
• Manufacturer (Section D): SYNCARDIA SYSTEMS, INC.; tucson AZ
• Manufacturer Contact: carole marcot, esq, vp, ra ; 1992 e. silverlake rd.; tucson, AZ 85713 ; 5205451234
• MDR Report Key: 4613726
• MDR Text Key: 16071722
• Report Number: 3003761017-2015-00106
• 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
• Remedial Action: Modification/Adjustment
• Type of Report: Initial
• Report Date: 02/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2016
• Device Model Number: TAH-T
• Device Lot Number: 090258
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/09/2015
• Initial Date FDA Received: 03/16/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2013
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 57 YR