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

Catalog Number 595000-001

Device Problem Device Alarm System (1012)

Patient Problem High Blood Pressure/ Hypertension (1908)

Event Date 09/23/2014

Event Type  malfunction  

Event Description

The customer reported that the freedom driver exhibited a fault alarm while supporting a pt.The customer also reported that the pt was singing at church when the fault alarm occurred.The pt was subsequently switched to the backup freedom driver without adverse impact.The customer reported that the pt was seen in clinic earlier that day and was slightly hypertensive, the clinical staff increased his dosage of lisinopril.At the time of alarm, the pt had two fully charged onboard batteries and was not connected to the a/c power supply.The pt believes the driver alarmed because of his hypertension.Although the freedom driver exhibited a fault alarm, the driver continued to function as intended.This alleged failure mode poses a low risk to the pt because it does not prevent the freedom driver from performing its life-sustaining functions.The freedom driver will be returned to syncardia for eval.The results of the investigation will be provided in a supplemental mdr.

• Brand Name: SYNCARDIA FREEDOM DRIVER
• 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: 4226707
• MDR Text Key: 18034266
• Report Number: 3003761017-2014-00188
• 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: 09/23/2014

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?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/23/2014
• Initial Date FDA Received: 10/14/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/01/2011
• 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: 58 YR