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

Catalog Number 295025-001

Device Problem Material Separation (1562)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/07/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

On (b)(6) 2015, this incident was initially reported as a service repair request by the customer.After preliminary investigation, it was determined on (b)(6) 2015, that the reported issue needed to be reclassified as a reportable event.The customer reported that the freedom onboard battery housing is separated.The customer also reported that the patient subsequently exchanged the freedom onboard battery.There was no reported adverse patient impact.This alleged failure mode poses a low risk to the patient because although the freedom onboard battery housing is separated, it 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 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

On september 7th, 2015, this incident was initially reported as a service repair request by the customer.After preliminary investigation, it was determined on (b)(6) 2015, that the reported issue needed to be reclassified as a reportable event.The customer reported that the freedom onboard battery housing is separated.The customer also reported that the patient subsequently exchanged the freedom onboard battery.There was no reported adverse patient impact.The freedom onboard battery was returned to syncardia for evaluation.Visual inspection of the onboard battery revealed that the housings were separated, confirming the customer-reported issue.It is unknown how the onboard battery's housing became separated; therefore, the root cause could not be determined.Review of the smbus (smart management bus) data revealed that the onboard battery exhibited a permanent fault.The smbus is the communication protocol used to communicate with the freedom onboard batteries.The smbus lifetime data revealed a maximum lifetime cell voltage of 4684 mv, which exceeds the internal secondary hardware protection threshold of 4400 mv.This data is consistent with the cause of the permanent fault and permanent disabling of the onboard battery's output.Because the onboard battery was permanently disabled, no functional testing could be performed.The customer reported issue poses a low risk to a patient because it would not prevent the freedom driver from performing its life-sustaining functions.The freedom driver has a redundant power source of external wall power, and patients are provided with several onboard batteries.The patient was provided with additional onboard batteries.Because freedom onboard battery s/n (b)(4) exhibited housing separation and was permanently disabled by its internal safety circuitry, it was taken out of service.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: 5184834
• MDR Text Key: 30271070
• Report Number: 3003761017-2015-00367
• Device Sequence Number: 1
• Product Code: LOZ
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P030011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 09/07/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2015
• 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: 09/11/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/18/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/08/2015
• 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: 42 YR