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

Catalog Number 295025-001

Device Problems Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)

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

Event Date 12/11/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The reported issues involve the following syncardia temporary total artificial heart (tah-t) system components and are reported under two separate medical device reports: freedom onboard battery s/n (b)(4) (mfr report # 3003761017-2015-00427) and freedom onboard battery s/n (b)(4) (mfr report # 3003761017-2015-00431).The customer reported that on (b)(6) 2015, freedom onboard batteries s/n (b)(4) and (b)(4) caused battery alarms on the freedom driver that was supporting a patient.The customer also reported that the patient subsequently exchanged the freedom onboard batteries.There was no reported adverse patient impact.This alleged failure mode poses a low risk to the patient because although the freedom onboard batteries caused a battery alarm on the driver, 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 batteries 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

The reported issue involves the following syncardia temporary total artificial heart (tah-t) system components and are reported under two separate medical device reports: freedom onboard battery s/n (b)(4)(mfr report # 3003761017-2015-00427) and freedom onboard battery s/n (b)(4) (mfr report # 3003761017-2015-00431).The customer reported that on october 10, 2015, freedom onboard batteries s/n (b)(4) caused battery alarms on the freedom driver that was supporting a patient.The customer also reported that the patient subsequently exchanged the freedom onboard batteries.There was no reported adverse patient impact.Freedom onboard battery s/n (b)(4) was returned to syncardia for evaluation.Visual inspection of the onboard battery revealed no anomalies.The onboard battery was connected to battery evaluation software, and analysis of the data revealed no permanent faults, anomalous values or communications issues.The onboard battery was functionally tested and passed all performance test criteria.Additional testing was conducted by inserting the onboard battery into each of the battery wells of a freedom driver, and each time, no alarms occurred.The reported battery alarms were not reproduced.During investigation testing, the onboard battery performed as intended, and there was no evidence of a malfunction.The onboard battery was returned to clinical use.The reported issue posed a low risk to the patient because it did not prevent the patient's 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.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: 5323089
• MDR Text Key: 34928931
• Report Number: 3003761017-2015-00431
• 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: 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: 12/23/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/20/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/23/2015
• 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: 59 YR