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

Catalog Number 595000-001

Device Problems Mechanical Problem (1384); Device Operates Differently Than Expected (2913)

Patient Problems No Consequences Or Impact To Patient (2199); No Code Available (3191)

Event Date 12/09/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer reported that the patient kept pressing the battery release button on the freedom driver and could not get the battery out of the driver.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 onboard battery was stuck in the driver, the freedom driver continued to perform its life-sustaining functions.The freedom driver has a redundant power source of external power.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 patient kept pressing the battery release button on the freedom driver and could not get the onboard battery out of the driver.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 confirmed that an onboard battery was in the left battery well, and it could not be removed by pressing the battery release button.The dummy battery was removed from the right battery well, and visual inspection revealed that the battery safety latch in the right battery well was broken.The root cause of the reported issue was the broken right battery safety latch, which prevented the left onboard battery from being removed and was likely the result of a forceful insertion or extraction of an onboard battery.The battery safety latch was replaced, the driver was serviced, and it passed all final performance testing.Testing included confirmation that onboard batteries could be inserted and removed from both battery wells.This failure mode posed a low risk to the patient because although the freedom onboard battery was stuck in the driver, the freedom driver continued to perform its life-sustaining functions.In addition, the freedom driver has a redundant power source of external power.The freedom driver will be returned to syncardia for evaluation.The results of the investigation will be provided in a follow-up mdr.

• 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: 5323558
• MDR Text Key: 34925187
• Report Number: 3003761017-2015-00429
• 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 faci
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Repair
• Type of Report: Initial,Followup
• Report Date: 12/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2015
• 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?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/22/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/26/2015
• 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: 26 YR