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

Catalog Number 295025-001

Device Problems Battery Problem (2885); Temperature Problem (3022)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/22/2019

Event Type  malfunction  

Manufacturer Narrative

This alleged failure mode poses a low risk to the patient because 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 s/n (b)(4) has been returned to syncardia for evaluation.Upon inspection, freedom onboard batteries s/n (b)(4) were returned in cardboard box with minimal bubble wrap.S/n (b)(4) had visible damage.The battery housing was cracked.The results of the investigation will be provided in a follow-up mdr.(b)(4); (3 of 3).

Event Description

The reported issue is reported under three separate medical device reports: (1) freedom driver s/n (b)(4) (mfr report # 3003761017-2019-00047), (2) freedom onboard battery s/n (b)(4) (mfr report # 3003761017-2019-00054) amd (3) freedom onboard battery s/n (b)(4) (mfr report # 3003761017-2019-00055).The customer, a syncardia certified hospital, reported that the freedom driver exhibited a temperature alarm or fault alarm while supporting a patient.The customer also reported the freedom driver and the two freedom onboard batteries s/n (b)(4) were very hot.The customer also reported that the patient was switched to a backup driver without any adverse patient impact.

Manufacturer Narrative

The customer-reported alarm was reproduced during investigation testing when a temperature alarm sounded during the observation test run.The root cause was determined to be the inability of the exhaust fan to operate due to the observed damage.The physical damage was most likely caused by rough handling or an impact shock to the driver.Previous investigations have shown that onboard batteries will feel hot to the touch (as reported by the customer) when the internal temperature of the driver exceeds its labeled specification of 40 degrees celsius.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.Ce 4686 follow-up report 1 (3 of 3).

• Brand Name: SYNCARDIA FREEDOM ONBOARD BATTERY
• Type of Device: BATTERY
• Manufacturer (Section D): SYNCARDIA SYSTEMS, LLC; 1992 e. silverlake road; tucson AZ 85713
• MDR Report Key: 8443971
• MDR Text Key: 139700076
• Report Number: 3003761017-2019-00055
• Device Sequence Number: 1
• Product Code: LOZ
• Combination Product (y/n): N
• PMA/PMN Number: P030011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 06/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2019
• 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: 03/11/2019
• Date Manufacturer Received: 02/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 71 YR