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

Model Number 295025-001

Device Problem Battery Problem (2885)

Patient Problem Loss of consciousness (2418)

Event Date 07/29/2019

Event Type  Injury  

Manufacturer Narrative

Visual inspection of the freedom driver revealed a broken external connector on the connection 1 receptacle cable and housing bosses with raised inserts.Despite the observed damage, the freedom driver passed all functional testing requirements.Additionally, an onboard battery discharge/recharge test was performed on the driver and it functioned as intended and charged the inserted onboard batteries.There was no evidence of a device malfunction with the driver related to the customer-reported issue.The fault alarm recorded in the driver's alarm history was likely due to the observed physical damage to the driver and was most likely one of the alarms reported by the customer.The onboard batteries returned with the driver and reported to be in use during the time of the reported driver stop were individually evaluated and found to be non-functional even though a remaining charge was recorded during the evaluation tests.The batteries were determined to be permanently disabled; therefore they could not provide source power to the driver.The root cause of the disabled, nonfunctional batteries could not be determined.The root cause of the customer-reported driver stop upon the insertion of onboard batteries was determined to be a malfunction of the onboard batteries as they were permanently disabled and not able to source power to the driver.Both the freedom driver system operator manual and the freedom driver system guidebook for patients and caregivers state that the freedom driver should have at least two sources of power to operate.Caution statements throughout both the operator manual and guidebook warn of the importance of connecting to external power or replacing depleted onboard batteries, as the onboard batteries will eventually lose power and the freedom driver will not function if it is not connected to external power.Section 5.2 of the guidebook states: "it is recommended that the freedom driver have at least two sources of power to operate.Plug in the freedom driver to an external power source when replacing an onboard battery." syncardia has a corrective and preventive action (capa) to address the inability of the user to detect when a freedom onboard battery is disabled.Syncardia has completed its evaluation of this complaint and is closing this file.(b)(4) initial (2 of 2).

Event Description

The customer-reported issue involves the following syncardia temporary total artificial heart (tah-t) system components and is reported under two separate medical device reports: (1) freedom onboard battery s/n (b)(4) (mfr report # 3003761017-2019-00257) and (2) freedom onboard battery s/n (b)(4) (mfr report # 3003761017-2017-00258).The customer, a syncardia certified hospital, reported that the patient's freedom driver exhibited intermittent fault alarms and the patient felt fine.The patient proceeded to exchange the two freedom onboard batteries in his freedom driver.He exchanged the first battery with no issue; however, after he exchanged the second battery the freedom driver stopped and the patient lost consciousness.The patient's caregiver changed the patient to his backup freedom driver and he regained consciousness and was airlifted to the hospital.The customer also reported that once at the hospital, the patient was subsequently changed to a companion 2 driver for evaluation.The patient had a very good full eject flag and was slightly fluid overloaded and his blood pressure was in the normal range.The patient was placed back on his backup freedom driver.The customer also reported that the patient did not test the onboard batteries prior to insertion into the freedom driver and that the batteries appeared to be completely drained.

• Brand Name: SYNCARDIA FREEDOM ONBOARD BATTERY
• Type of Device: BATTERY
• Manufacturer (Section D): SYNCARDIA SYSTEMS, LLC; 1992 e. silverlake road; tucson AZ 85713
• Manufacturer Contact: kerri hensley ; 1992 e. silverlake road; tucson, AZ 85713 ; 5205451234
• MDR Report Key: 8939826
• MDR Text Key: 156922227
• Report Number: 3003761017-2019-00258
• Device Sequence Number: 1
• Product Code: LOZ
• UDI-Device Identifier: 00858000003084
• UDI-Public: (01)00858000003084
• 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
• Type of Report: Initial
• Report Date: 08/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 295025-001
• Device Catalogue Number: 295025-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/29/2019
• Was Device Evaluated by Manufacturer?: Yes
• 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 Outcome(s): Life Threatening
• Patient Age: 59 YR