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

Catalog Number 295025-001

Device Problem Failure to Charge (1085)

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

Event Date 08/14/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer reported that the freedom onboard battery did not hold a charge.There was no reported adverse patient impact.This alleged failure mode poses a low risk to the 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 power.In addition, patients are provided with several onboard batteries.The onboard battery will be returned to syncardia for evaluation.The results of the investigation will be provided in a supplemental mdr.

Manufacturer Narrative

(b)(4).

Event Description

The customer reported that the freedom onboard battery did not hold a charge.There was no reported adverse patient impact.The freedom onboard battery was returned to syncardia for evaluation.Physical inspection of onboard battery s/n (b)(4) revealed no anomalies.The reported fault condition was confirmed through evaluation of the battery's smbus (system management bus) data.The smbus data is the communication protocol used communicate with the freedom onboard batteries.The root cause for onboard battery s/n (b)(4) not charging was the result of the battery being permanently disabled by its internal safety circuitry.The battery experienced a high pack voltage event while charging, and this prompted the internal safety circuitry to permanently disable the battery's input/output.Because the onboard battery was permanently disabled, no further evaluation could be performed.This 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.Because freedom onboard battery s/n (b)(4) was permanently disabled, it has been 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: 5019786
• MDR Text Key: 24668971
• Report Number: 3003761017-2015-00263
• 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: Replace
• Type of Report: Followup
• Report Date: 08/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 09/01/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/20/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/11/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/13/2015
• 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: 24 YR