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

Catalog Number 595000-001

Device Problems False Alarm (1013); Device Displays Incorrect Message (2591)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 05/25/2015

Event Type  malfunction  

Event Description

The customer reported that the freedom driver exhibited a fault alarm while the pt was lying down and watching television.The customer also reported that the driver was connected to wall power through the freedom ac power supply when the alarm sounded.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 driver exhibited a fault alarm, 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 exhibited a fault alarm while the patient was lying down and watching television.The customer also reported that the driver was connected to wall power through the freedom ac power supply when the alarm sounded.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 driver's internal components revealed two missing screws and lock washers, raised pem nuts on the two top bosses, skewed speaker ribbon cables, a broken scotch yoke within the piston and cylinder assembly (pca), a broken u21 pressure sensor on the main printed circuit board assembly (pcba), and damage to the primary motor and main pcba.At incoming testing, the driver immediately exhibited an irreversible fault alarm and operated on the secondary motor after four to five seconds of alarm annunciation, confirming the customer-reported issue.Despite operation on the secondary motor and the fault alarm, the driver met all acceptance criteria of pressure test requirements associated with normotensive and hypertensive settings.The root cause of the customer-reported fault is unknown but the damaged observed is consistent with an impact shock, which caused the scotch yoke to break, sometime before the customer experience.Although at different locations, the top dead center (tdc) and bottom dead center (bdc) sensors detect the movement of the scotch yoke.When the scotch yoke is not passing either sensor, tdc or bdc time-out faults will occur for the corresponding sensor, resulting in a fault alarm.The customer-reported fault alarm posed a low risk to the patient because the driver continued to perform its life-sustaining functions.The driver was serviced, which included the replacement of main pcba, primary motor, secondary motor, speaker pcba, primary motor controller pcba, front housing, and rear housing.The freedom driver passed all functional and performance testing 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 Contact: carole marcot ; 1992 e. silverlake road; tucson, AZ 85713 ; 5205451234
• MDR Report Key: 4841686
• MDR Text Key: 5941737
• Report Number: 3003761017-2015-00183
• 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: 05/25/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2015
• 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: 04/09/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/08/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2014
• 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: 41 YR