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 Consequences Or Impact To Patient (2199); No Patient Involvement (2645)

Event Date 11/20/2014

Event Type  malfunction  

Event Description

This onboard battery was not in use in a patient's freedom driver.The customer reported that when he placed the freedom onboard battery into the freedom battery charger, the freedom onboard battery would not charge despite being on the freedom onboard charger for 12 hours.This alleged failure mode poses a low risk to a patient because the issue was observed when the freedom onboard battery was not in patient use.An investigation will be conducted by syncardia.The results of the investigation will be provided in a supplemental mdr.

Manufacturer Narrative

(b)(4).

Event Description

This onboard battery was not in use in a patient's freedom driver.The customer reported that when he placed the freedom onboard battery into the freedom battery charger, the freedom onboard battery would not charge despite being on the freedom onboard battery charger for 12 hours.Freedom onboard battery s/n (b)(4) was returned to syncardia for evaluation.Visual inspection of the exterior of the battery did not reveal any physical anomalies.The customer reported issued was verified during functional testing.The battery did not charge or provide power output.The root cause for the battery's disabled output is unknown; however, analysis of the electronic data (smbus) recorded data indicates that the battery was subjected to an over-discharge event.The secondary cell supervisor circuit detected an unsafe condition and initiated a permanent fault input flag signal which disabled the battery.The secondary cell circuitry does not record the cause of the fault condition.Despite the malfunction of the freedom onboard battery, risk to the patient was low because the freedom driver has multiple redundant power sources and the patient is provided with additional backup freedom onboard batteries.The patient was provided with a replacement freedom onboard battery.There was no adverse impact on the patient.The freedom onboard battery was taken out of service.

• 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; cd 2486; tucson, AZ 85713 ; 5205451234
• MDR Report Key: 4352481
• MDR Text Key: 5175355
• Report Number: 3003761017-2014-00282
• 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 Facility,health professional,use
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/20/2014

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: Other Health Care Professional
• Device Catalogue Number: 295025-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/25/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/20/2014
• Initial Date FDA Received: 12/11/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2012
• 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
• Patient Age: 26 YR