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

Catalog Number 295025-001

Device Problems Battery Problem (2885); Medical Gas Supply Problem (2985); Moisture or Humidity Problem (2986)

Patient Problems Loss of consciousness (2418); No Known Impact Or Consequence To Patient (2692)

Event Date 10/02/2015

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: (1) primary freedom driver s/n (b)(4) (mfr report # 3003761017-2015-00327 and (2) freedom onboard battery s/n (b)(4) (mfr report # 3003761017-2015-00350).The customer reported that on (b)(6) 2015, the freedom driver exhibited a fault alarm while supporting a patient that was working in his garage.The customer also reported that the patient immediately changed the freedom onboard batteries and the alarm resolved.The customer also reported that one of the four batteries, freedom onboard battery s/n (b)(4), only had one bar remaining of power at the time of the event.The patient reported that there was no battery alarm and that the freedom onboard battery s/n (b)(4) was fully charged 30 minutes prior to the fault alarm.The customer also reported that on (b)(6) 2015, the freedom driver exhibited another fault alarm with freedom onboard battery s/n (b)(4) while the patient was out shopping with his spouse.Freedom onboard battery s/n (b)(4) went from fully charged to one bar without a battery alarm prior to the fault alarm.The patient switched out the battery and the alarm resolved and the patient continued shopping.The customer also reported that while the patient and his spouse were loading up the car, the patient reported "not feeling well" and the freedom driver exhibited a fault alarm.At the same time of the fault alarm, the patient lost consciousness while sitting in his vehicle.The customer also reported that the patient regained consciousness after approximately 30 seconds.The patient was subsequently switched to the backup freedom driver.The patient felt fine after the driver switch.The customer also reported that the patient was assessed by the medical staff and was alert, oriented, stable, and able to walk without issue.The patient denied having any shortness of breath or any other symptoms.The freedom onboard battery 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 issues involve the following syncardia temporary total artificial heart (tah-t) system components and are reported under two separate medical device reports: primary freedom driver s/n (b)(4) (mfr report # 3003761017-2015-00327 and freedom onboard battery s/n (b)(4) (mfr report # 3003761017-2015-00350).The customer reported that on (b)(6) 2015, the freedom driver exhibited a fault alarm while supporting a patient that was working in his garage.The customer also reported that the patient immediately changed the freedom onboard batteries and the alarm resolved.The customer also reported that one of the four batteries, freedom onboard battery s/n (b)(4), only had one bar remaining of power at the time of the event.The patient reported that there was no battery alarm and that the freedom onboard battery s/n (b)(4) was fully charged 30 minutes prior to the fault alarm.The customer also reported that on (b)(6) 2015, the freedom driver exhibited another fault alarm with freedom onboard battery s/n (b)(4) while the patient was out shopping with his spouse.Freedom onboard battery s/n (b)(4) went from fully charged to one bar without a battery alarm prior to the fault alarm.The patient switched out the battery and the alarm resolved and the patient continued shopping.The customer also reported that while the patient and his spouse were loading up the car, the patient reported "not feeling well" and the freedom driver exhibited a fault alarm.At the same time of the fault alarm, the patient lost consciousness while sitting in his vehicle.The customer also reported that the patient regained consciousness after approximately 30 seconds.The patient was subsequently switched to the backup freedom driver.The patient felt fine after the driver switch.The customer also reported that the patient was assessed by the medical staff and was alert, oriented, stable, and able to walk without issue.The patient denied having any shortness of breath or any other symptoms.The freedom driver and freedom onboard battery were returned to syncardia for evaluation.The investigation for freedom driver s/n (b)(4) (mfr report # 3003761017-2015-00327) determined that the driver performed as intended, there was no evidence of a device malfunction and no evidence that the driver stopped pumping.Visual inspection of the onboard battery revealed no anomalies.The onboard battery was connected to battery evaluation software, and initially there was no evidence of any anomalies in the data.However, upon application of holding force and depression of the fuel gauge button, the onboard battery exhibited intermittent data, specifically associated with battery cell 4.This confirmed the reported issue.The root cause for the intermittent functionality was likely the result of an intermittent anode tab connection.When the onboard battery was docked in a freedom battery charger, the onboard battery did not exhibit any signs of charging when its fuel gauge button was depressed.The onboard battery eventually exhibited a hard fault and its output was disabled.The onboard battery was taken out of service.The patient's reported adverse event was not related to the malfunction of freedom onboard battery s/n (b)(4).The customer reported that this onboard battery was switched and the freedom driver battery alarm resolved while the patient was shopping.The patient's reported adverse event occurred after shopping, and he regained consciousness prior to switching from freedom driver s/n (b)(4) to the backup freedom driver.The freedom driver system guidebook for patients and caregivers (f-900014-en), at section 6.3, "power management," recommends to patients and caregivers that whenever possible, they should connect the freedom driver to an external power source when replacing an onboard battery, and if an external power source is not available, promptly insert another charged onboard battery into the freedom driver.Patients and caregivers are also instructed to carry at least two additional onboard batteries with them.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: 5142263
• MDR Text Key: 28401141
• Report Number: 3003761017-2015-00350
• 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: 10/04/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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: 10/08/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/10/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/02/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/09/2015
• 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 Outcome(s): Required Intervention
• Patient Age: 66 YR