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

Catalog Number 595000-001

Device Problem Noise, Audible (3273)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/24/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer reported that the patient's freedom driver was "very noisy." the customer also reported that the patient was switched to the backup freedom driver.There was no reported adverse patient impact.This alleged failure mode poses a low risk to the patient because 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 follow-up mdr.

Manufacturer Narrative

(b)(4) fup 1.

Event Description

The customer reported that the patient's freedom driver was "very noisy." the customer also reported that the patient was switched to the backup freedom driver.There was no reported adverse patient impact.The freedom driver was returned to syncardia for evaluation.Visual inspection of the external and internal components revealed no anomalies.Review of the alarm history (eeprom) revealed one alarm code that occurred during the manufacturing/service process.No alarms were reported by the customer.The freedom driver was tested, and it met all test acceptance criteria, including normotensive and hypertensive patient simulator settings, with no anomalies, unintended alarms or abnormally loud noise.The driver was then tested for an additional 48 hours at normotensive patient simulator settings and performed as intended.The reported noise was not heard during investigation testing.The investigation concluded that the freedom driver performed as intended, and there was no evidence of a device malfunction.The freedom driver was serviced and passed all final performance testing.The reported issue posed a low risk to the patient because the freedom driver continued to perform its life-sustaining functions.This issue will continue to be monitored and trended as part of the customer experience process.Syncardia has completed its evaluation of this complaint and is closing this file.

• Brand Name: SYNCARDIA FREEDOM DRIVER
• Type of Device: EXTERNAL PNEUMATIC DRIVER
• Manufacturer (Section D): SYNCARDIA SYSTEMS, INC.; 1992 e. silverlake road; tucson AZ 85713
• Manufacturer Contact: carole marcot ; 1992 e. silverlake road; tucson, AZ 85713 ; 5205451234
• MDR Report Key: 5683870
• MDR Text Key: 46295698
• Report Number: 3003761017-2016-00227
• Device Sequence Number: 1
• Product Code: LOZ
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P030011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 05/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2016
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/29/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/13/2012
• 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: 71 YR