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

Catalog Number 595000-001

Device Problems Device Operates Differently Than Expected (2913); Noise, Audible (3273)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/08/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer reported that the freedom driver exhibited abnormal noises while supporting a patient.The customer also reported that the patient was subsequently 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 although the freedom driver exhibited abnormal noises, 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).

Event Description

The customer reported that the freedom driver exhibited abnormal noises while supporting a patient.The customer also reported that the patient was subsequently 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 abnormalities.The freedom driver was tested and it passed all test acceptance criteria, including normotensive and hypertensive patient simulator settings, with no anomalies, unusual noises or unintended alarms.The driver was then tested for an additional 48 hours under normotensive patient simulator settings and performed as intended.The reported abnormal noises were not reproduced during investigation testing.The investigation determined that the freedom driver performed as intended, and there was no evidence of a device malfunction.The 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: 5838074
• MDR Text Key: 52176808
• Report Number: 3003761017-2016-00265
• Device Sequence Number: 1
• Product Code: LOZ
• UDI-Device Identifier: 00858000003121
• UDI-Public: (01)00858000003121
• 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 faci
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 07/08/2016

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/08/2016
• Initial Date FDA Received: 08/01/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/30/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/20/2012
• 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: 62 YR