MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, LLC SYNCARDIA FREEDOM ONBOARD BATTERY

Catalog Number 295025-001

Device Problems Self-Activation or Keying (1557); Charging Problem (2892)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/24/2016

Event Type  malfunction  

Manufacturer Narrative

This alleged failure mode poses a low risk to the patient because the reported issue would not prevent the freedom driver from performing its life-sustaining functions.In addition, the freedom driver is equipped with multiple redundant power sources (e.G., external power via ac power supply and car charger) and patients are provided with several freedom onboard batteries.The freedom onboard battery will be returned to syncardia for evaluation.The results of the investigation will be provided in a follow-up mdr.(b)(4).

Event Description

The customer, a syncardia certified hospital, reported that the patient's freedom onboard battery was unable to charge and when the indicator button was pressed, the led light did not illuminate.The customer also reported that the patient was given a replacement freedom onboard battery.There was no reported adverse patient impact.

Manufacturer Narrative

The freedom onboard battery was returned to syncardia for evaluation.Review of the system management bus (smbus) data revealed that the onboard battery exhibited a permanent fault and was permanently disabled by its safety monitor.The root cause for the onboard battery's disabled output could not be determined.However analysis of the smbus recorded data indicated that the onboard battery was subjected to a deep discharge event, causing extreme cell under-voltage conditions.Because of the cell under-voltage parameters being outside of the internal safety firmware design limits, the onboard battery's input/output functions were permanently disabled, resulting in the reported inability to charge.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.(b)(4) follow-up report 1.

Event Description

The customer, a syncardia certified hospital, reported that the patient's freedom onboard battery was unable to charge and when the indicator button was pressed, the led light did not illuminate.The customer also reported that the patient was given a replacement freedom onboard battery.There was no reported adverse patient impact.

• Brand Name: SYNCARDIA FREEDOM ONBOARD BATTERY
• Type of Device: BATTERY
• Manufacturer (Section D): SYNCARDIA SYSTEMS, LLC; 1992 e. silverlake road; tucson AZ 85713
• Manufacturer Contact: carole marcot ; 1992 e. silverlake road; tucson, AZ 85713 ; 5205451234
• MDR Report Key: 6151483
• MDR Text Key: 62315178
• Report Number: 3003761017-2016-00382
• 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,u
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 11/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 295025-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/20/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2014
• 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: 34 YR