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

Catalog Number 595000-001

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem High Blood Pressure/ Hypertension (1908)

Event Date 11/19/2014

Event Type  malfunction  

Event Description

The customer reported that the freedom driver exhibited went to the hospital and was switched to a backup freedom driver without adverse impact.The customer also reported that the patient was experiencing high blood pressure and was given medication to stabilize his blood pressure.The freedom driver was switched off the patient and inspected.The driver continued to give a fault alarm once the freedom onboard battery was inserted.Although the freedom driver exhibited a battery alarm, the driver continued to function as intended.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.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: CIRCULATORY ASSIST DEVICE
• Manufacturer (Section D): SYNCARDIA SYSTEMS, INC.; tucson AZ
• Manufacturer Contact: carole marcot, esq., vp ; 1992 e. silverlake rd.; ce 2484; tucson, AZ 85713 ; 5205451234
• MDR Report Key: 4352482
• MDR Text Key: 5199795
• Report Number: 3003761017-2014-00281
• Device Sequence Number: 1
• Product Code: LOZ
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P030011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 11/19/2014

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: Lay User/Patient
• Device Catalogue Number: 595000-001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/19/2014
• Initial Date FDA Received: 12/11/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/01/2012
• 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: 70 YR