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

Catalog Number 595000-001

Device Problem Device Displays Incorrect Message (2591)

Patient Problems No Consequences Or Impact To Patient (2199); Discomfort (2330)

Event Date 12/29/2014

Event Type  malfunction  

Event Description

A syncardia clinical support specialist reported that the freedom driver exhibited several intermittent fault alarms while supporting a pt.The pt was taken to the hosp by his wife and was subsequently switched to a companion 2 driver.The pt reported feeling frustrated about the intermittent fault alarms while being supported by this freedom driver.After three days in the hosp, the pt was switched back to a freedom driver and was discharged to home.There was no permanent adverse pt impact.This alleged failure mode poses a low risk to the pt, 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 eval.The results of the investigation will be provided in a supplemental mdr.

Manufacturer Narrative

Manufacturer Narrative

(b)(4).

Event Description

A syncardia clinical support specialist reported that the freedom driver exhibited several intermittent fault alarms while supporting a patient.A syncardia clinical support specialist also reported that the patient was taken to the hospital by his wife and was subsequently switched to a companion 2 driver.The patient reported feeling frustrated about the intermittent fault alarms while being supported by this freedom driver.After three days in the hospital, the patient was switched back to a freedom driver and was discharged to home.There was no permanent adverse patient impact.The freedom driver was returned to syncardia for evaluation.Visual inspection of the external and internal components of the driver revealed no abnormalities.Review of the electronic data did not reveal any new alarms while the driver was in patient use.Only permanent, non-recoverable fault alarms are recorded in the electronic data.Intermittent, recoverable and battery alarms are not recorded in the electronic data.The freedom driver in as received condition passed all test requirements with no anomalies or alarms.The customer reported fault alarms were not duplicated during functional testing.The driver performed as intended, and there was no evidence of a device malfunction.In addition, the driver was tested for an additional 48 hours and performed as intended with no issues.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.This issue will continue to 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: 4484371
• MDR Text Key: 5349476
• Report Number: 3003761017-2015-00023
• 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,Company Representative,company representati
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 12/29/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 595000-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/19/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/09/2011
• 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