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

Catalog Number 295025-001

Device Problems Low Battery (2584); Charging Problem (2892)

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

Event Date 06/04/2017

Event Type  malfunction  

Manufacturer Narrative

This alleged failure mode poses a low risk to the patient because although the freedom onboard batteries had a low capacity, they did not prevent the freedom 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 batteries will be returned to syncardia for evaluation.The results of the investigation will be provided in a follow-up mdr.

Event Description

The reported issue involves two freedom onboard batteries that are reported under two separate medical device reports: (1) freedom onboard battery s/n (b)(4) (mfr report # 3003761017-2017-00099) and (2) freedom onboard battery s/n (b)(4) (mfr report # 3003761017-2017-00100).The customer, a syncardia certified hospital, reported that the patient's freedom onboard batteries had a low capacity.There was no reported patient impact.

Manufacturer Narrative

The freedom onboard battery was returned to syncardia for evaluation.The customer-reported low capacity was confirmed during the system management (smbus) data review to be at or below the capacity threshold.Investigation testing subjected the battery to the freedom onboard battery evaluation procedure, which caused the battery monitor firmware to reset the calculated capacity based on a full charge and discharge cycle.Following the evaluation process, the battery's capacity was successfully reset to acceptable levels and the reported low capacity issue was corrected.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 (1 of 2).

Event Description

The reported issue involves two freedom onboard batteries that are reported under two separate medical device reports: (1) freedom onboard battery s/n (b)(4) (mfr report # 3003761017-2017-00099) and (2) freedom onboard battery s/n (b)(4) (mfr report # 3003761017-2017-00100).The customer, a syncardia certified hospital, reported that the patient's freedom onboard batteries had a low capacity.There was no reported 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: michael garippa ; 1992 e. silverlake road; tucson, AZ 85713 ; 5205451234
• MDR Report Key: 6637478
• MDR Text Key: 77646781
• Report Number: 3003761017-2017-00099
• 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: Health Professional
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 06/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2017
• 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: 06/09/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/11/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2014
• 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: 35 YR