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

Catalog Number 595000-001

Device Problem Device Displays Incorrect Message (2591)

Patient Problems Fatigue (1849); Tingling (2171); No Consequences Or Impact To Patient (2199)

Event Date 04/03/2015

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 complained of "having symptoms" including fatigue, bilateral hand tingling and right facial tingling.The patient was switched to the backup freedom driver.The customer also reported that after the patient was switched to the backup driver, the patient "felt better," and his symptoms resolved.There was no reported adverse patient impact.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.

Manufacturer Narrative

The driver passed all testing and pressure performance testing associated with nominal normotensive and hypertensive settings with no anomalies or alarms.In addition, the driver was tested for an add'l 48 hours and performed as intended with no issues.The customer experience was not duplicated, and there was no evidence of a device malfunction.The rubber foot was replaced, the driver was serviced and passed all final performance testing.The reported issue poses a low risk to the pt because it does not prevent the freedom driver from performing its life-sustaining functions.This issue will continue to monitored and trended as part of the customer experience process.Syncardia has completed its eval of this complaint and is closing this file.

Event Description

The customer reported that the freedom driver exhibited intermittent fault alarms while supporting a pt.The customer also reported that the pt complained of "having symptoms" including fatigue, bilateral hand tingling and right facial tingling.The pt was switched to the backup freedom driver.The customer also reported that after the pt was switched to the backup driver, the pt "felt better," and his symptoms resolved.The freedom driver was returned to syncardia for eval.Visual inspection of the exterior revealed a missing rubber foot.Review of the electronic data confirmed that the driver did not record a permanent fault alarm while supporting the pt.Only permanent fault alarms are latched in the eeprom record.Intermittent, recoverable, and battery alarms are not recorded.

• Brand Name: SYNCARDIA FREEDOM DRIVER
• Type of Device: CIRCULATORY ASSIST DEVICE
• Manufacturer (Section D): SYNCARDIA SYSTEMS, INC.; tucson AZ
• Manufacturer Contact: carole marcot,esq. ; 1992 e. silverlake rd.; tucson, AZ 85713 ; 5205451234
• MDR Report Key: 4703958
• MDR Text Key: 5724027
• Report Number: 3003761017-2015-00127
• 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,health professional,use
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 04/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 595000-001
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/09/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/03/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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: 61 YR