MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, INC. SYNCARDIA FREEDOM DRIVER; CIRCULATORY ASSIST DEVICE

Catalog Number 595000-001

Device Problems Filling Problem (1233); Device Operates Differently Than Expected (2913)

Patient Problem Low Cardiac Output (2501)

Event Date 09/19/2014

Event Type  malfunction  

Event Description

The customer reported that the patient experienced low fill volumes and low cardiac output while being supported by primary freedom driver 4550 (see mfr report 3003761017-2014-00178).The patient switched to the backup freedom driver 4500, but continued to experience low fill volumes and low cardiac output.The patient was switched to a companion 2 driver without adverse impact.The customer also reported that the patient is still fluid overloaded, but his condition is improving.This alleged failure mode poses a low risk to the patient because it does not prevent the freedom driver from performing its life-sustaining functions.Although the patient experienced high full volumes, the freedom driver continued to function as intended.

Manufacturer Narrative

An investigation will be conducted by syncardia and the results will be provided in a supplemental mdr.

• Brand Name: SYNCARDIA FREEDOM DRIVER
• 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: 4272402
• MDR Text Key: 5226368
• Report Number: 3003761017-2014-00179
• 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: Replace
• Type of Report: Initial
• Report Date: 09/19/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 595000-001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/19/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/01/2011
• 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
• Patient Age: 26 YR