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

Catalog Number 595000-001

Device Problem False Alarm (1013)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/07/2014

Event Type  malfunction  

Event Description

The customer reported that the freedom driver exhibited a fault alarm while supporting a patient.The customer also reported that once the patient got into the car and connected to the freedom car charger the driver alarmed.There was no patient impact.The patient was subsequently switched to the backup freedom driver.Although the freedom driver exhibited a fault alarm, the 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.

Manufacturer Narrative

The freedom driver will be returned to syncardia for evaluation.The results of the investigation will be provided in a supplemental mdr.

Manufacturer Narrative

Review of the eeprom (alarm history) did not reveal a record of any permanent fault alarm that may have occurred while the driver was supporting the patient.Only permanent fault alarms are recorded in the eeprom record; intermittent, recoverable, and battery alarms are not recorded.The customer experience was not duplicated and root cause of the customer-reported alarm could not be determined.The freedom driver was serviced and passed all final performance testing.The reported issue posed a low risk to the patient because it does not prevent the freedom driver from performing its life-sustaining functions.This issue will continue to be monitored and trended as part of the customer experience process.Please note the initial mdr reported "the customer also reported that once the patient got into the car and connected to the freedom car charger, the driver alarmed." this has been corrected to "the customer reported that this alarm occurred when the patient got into the car and connected to the freedom car charger." syncardia has completed its evaluation of this complaint and is closing this file.

Event Description

The freedom driver was returned to syncardia for evaluation.The driver passed all performance testing with no anomalies or alarms.There was no evidence of a device malfunction.

• 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: 4280019
• MDR Text Key: 5035427
• Report Number: 3003761017-2014-00267
• 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: 11/07/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2014
• 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: 11/07/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/01/2011
• 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: 53 YR