MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, INC. SYNCARDIA FREEDOM DRIVER; EXTERNAL PNEUMATIC DRIVER

Catalog Number 595000-001

Device Problems Device Alarm System (1012); Failure to Charge (1085); Battery Problem (2885); Noise, Audible (3273)

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

Event Date 08/24/2015

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 # 3003761017-2015-00268 and (2) freedom onboard battery s/n (b)(4) (mfr report # 3003761017-2015-00269).The customer reported that the freedom driver exhibited a fault alarm while supporting a patient.The customer also reported that the fault alarm occured when the freedom onboard battery was inserted into the driver.The customer also reported that the freedom onboard battery was "not charged and was unable to be charged." the customer also reported that when fully charged batteries were inserted into the freedom driver, the fault alarm did not resolve.The patient was subsequently switched to the backup freedom driver.There was no reported adverse patient impact.This alleged failure mode poses a low risk to the patient because although the freedom driver exhibited a fault alarm, the freedom driver continued to perform its life-sustaining functions.The freedom driver will be returned to syncardia for evaluation.The results of the investigation will be provided in a follow-up mdr.

Manufacturer Narrative

(b)(4).Follow-up report 1.

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 # 3003761017-2015-00268 and freedom onboard battery s/n (b)(4) (mfr report # 3003761017-2015-00269).The customer reported that the freedom driver exhibited a fault alarm while supporting a patient.The customer also reported that the fault alarm occurred when the freedom onboard battery was inserted into the driver.The customer also reported that the freedom onboard battery was "not charged and was unable to be charged." the customer also reported that when fully charged batteries were inserted into the freedom driver, the fault alarm did not resolve.The patient was subsequently switched to the backup freedom driver.There was no reported adverse patient impact.The freedom driver was returned to syncardia for evaluation.Visual inspection of the driver's external and internal components revealed no abnormalities.The driver in "as received" condition passed all test requirements, which included nominal normotensive and hypertensive settings with no anomalies or alarms.The customer experience was not reproduced, and there was no evidence of a device malfunction.Review of the electronic data revealed a "speaker 2 voltage too low when off" fault, which is likely the alarm experienced by the customer.This alarm presents itself during onboard battery exchange while operating the freedom driver only on battery power.The other recorded faults ("secondary motor voltage too high" and "bottom dead center (bdc) time-out") do not occur during onboard battery exchange and, therefore, could not be the alarms described in the customer experience.The root cause of the customer-reported fault alarm was the result of freedom onboard battery s/n (b)(4) being permanently disabled by its internal safety circuitry because the parameters were outside of the internal safety firmware design limits.The customer-reported fault alarm posed a low risk to the patient because the freedom driver was not prevented from performing its life-sustaining functions.The driver was serviced before being placed into finished goods.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 DRIVER
• Type of Device: EXTERNAL PNEUMATIC DRIVER
• 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: 5039289
• MDR Text Key: 25240208
• Report Number: 3003761017-2015-00268
• 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: 08/24/2015

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: Lay User/Patient
• Device Catalogue Number: 595000-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/28/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/15/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/13/2014
• 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: 22 YR