MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, INC. SYNCARDIA FREEDOM ONBOARD BATTERY

Catalog Number 295025-001

Device Problems Failure to Charge (1085); Charging Problem (2892)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Date 12/11/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The freedom onboard battery was not supporting a patient.The customer reported that the hospital freedom onboard battery was unable to charge.This alleged failure mode poses a low risk to a patient because the issue was observed when the freedom driver was not supporting a patient.In addition, it would not prevent the driver from performing its life-sustaining functions.In addition, patients are provided with several onboard batteries, and the freedom driver has a redundant power source of external wall power.The freedom onboard battery 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

This freedom onboard battery was not in patient use.The customer reported that the freedom onboard battery was unable to charge.The onboard battery was returned to syncardia for evaluation.Visual inspection revealed no anomalies.The onboard battery was connected to battery evaluation software, and review of the data revealed that the onboard battery exhibited no permanent faults, but it was in a state of significant deep discharge.Its cells were in a "recovery charge" mode.The recovery charge mode can take up to 36 hours to correct a deeply discharged onboard battery.During the recovery charge mode, the onboard battery will appear to not charge, although it is charging at a very low rate.The onboard battery was inserted into a freedom battery charger.The deep discharge condition was corrected, and the onboard battery entered into the "fast-charge" mode to fully charge the onboard battery.The "freedom driver system guidebook for patients and caregivers" recommends that onboard batteries be fully charged at all times when not in use.The onboard battery was within its use life period at the time of the reported issue, with an expiration date of august 2016.Since the onboard battery will soon surpass its expiration date, it will be taken out of service.The reported issue posed a low risk to a patient because the issue was observed when the freedom onboard battery was not in patient use.In addition, it would not prevent a freedom driver from performing its life-sustaining functions.Patients are provided with several onboard batteries, and the freedom driver has a redundant power source of external wall power.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 ONBOARD BATTERY
• Type of Device: BATTERY
• 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: 5323158
• MDR Text Key: 34928888
• Report Number: 3003761017-2015-00428
• 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
• Type of Report: Initial,Followup
• Report Date: 12/11/2015

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: 295025-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/15/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/06/2012
• 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