MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, INC. SYNCARDIA FREEDOM DRIVER

Catalog Number 595000-001

Device Problems Volume Accuracy Problem (1675); Overfill (2404); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/17/2014

Event Type  malfunction  

Event Description

The customer reported that the freedom driver exhibited intermittent fault alarms while supporting a patient.The customer also reported that the patient was brought into the clinic for an evaluation.The customer also reported that the patient has a history of volume overload and the patient's sister reported intermittent fill volumes in the 30's.The patient was subsequently switched to the companion 2 driver at the clinic.While the patient was connected to the companion 2 driver, the physician was connected to the companion 2 driver, the physician reviewed the data on the companion 2 driver and confirmed that the patient was in volume overload.The patient was subsequently switched to a new primary freedom driver.There was no reported adverse patient impact.

Manufacturer Narrative

This alleged failure mode poses a low risk to the patient because although the freedom driver exhibited intermittent fault alarms, the freedom driver continued to perform its life-sustaining functions.The freedom driver will be returned to syncardia for evaluation.The results of the investigation will be provided in a supplemental mdr.

• Brand Name: SYNCARDIA FREEDOM DRIVER
• Type of Device: SYNCARDIA FREEDOM DRIVER
• 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: 4380584
• MDR Text Key: 5240527
• Report Number: 3003761017-2014-00321
• 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: 12/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 595000-001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/18/2014
• 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: 42 YR