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

Catalog Number 595000-001

Device Problems Loose or Intermittent Connection (1371); Mechanical Problem (1384)

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

Event Date 06/02/2015

Event Type  malfunction  

Event Description

The customer reported that the freedom driver sounds like there are loose parts on the inside of the device.The pt was subsequently switched to the backup freedom driver.There was no reported adverse pt impact.This alleged failure mode poses a low risk to the pt because although the freedom had loose parts on the inside of the device, 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

(b)(4).

Event Description

The customer reported that the freedom driver sounds like there are loose parts on the inside of the device.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 components of the driver revealed no abnormalities.No loose parts were found in the driver.No new electronic data fault alarms results were extracted from the driver, and the customer did not report any fault alarms.The driver in "as received" condition passed all required functional testing requirements with no anomalies or alarms.There was no evidence of loose parts during operation of the driver.There was no evidence of a device malfunction, and the driver continued to perform its life-sustaining functions during failure investigation testing.Risk to the patient was low because the driver continued to perform its life-sustaining functions.The driver was serviced which included the replacement of the main printed circuit board assembly (pcba) and the following components per days of use: speaker pcba, piston and cylinder assembly (pca), motor/gearbox assembly and motor controller pcbas, before being placed into finished goods.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 (Section G): 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: 4865871
• MDR Text Key: 5860097
• Report Number: 3003761017-2015-00200
• 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,User Facility,foreign,health profe
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 06/02/2015

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: 06/12/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/02/2015
• Initial Date FDA Received: 06/22/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/28/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2011
• 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: 58 YR