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

Catalog Number 595000-001

Device Problems Air Leak (1008); Device Displays Incorrect Message (2591)

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

Event Date 03/29/2016

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 three separate medical device reports: primary freedom driver s/n (b)(4) (mfr report # 3003761017-2016-00129), freedom ac power supply cord s/n (b)(4) (mfr report # 3003761017-2016-00130), and 70cc tah-t cannula s/n (b)(4) (mfr report # 3003761017-2016-00131).On (b)(6) 2016, the customer reported that the freedom driver s/n (b)(4) exhibited a fault alarm while supporting a patient.The customer also reported that the patient was sedentary and had 2 fully charged onboard batteries in the driver during the reported event.The customer also reported that the patient was subsequently switched to the backup freedom driver.The customer also reported that there was a significant amount of air leaking out of the 70cc temporary total artificial heart (tah-t) red cannula s/n (b)(4).The customer also reported that the tear "was circular, about half of the cannula and it was about 0.5cm above the white connector." the customer also reported that the 70cc tah-t cannulae were discolored and stiff.The customer also reported that the patient applied rescue tape at home to prevent cardiac output (co) loss and another fault alarm.The customer also reported that the 70cc tah-t cannula was successfully repaired by the hospital staff when the patient was taken to the hospital.There was no reported adverse patient impact as a result of the cannula tear and subsequent repair.The customer also reported that upon the patient's arrival to the hospital, it was noted that the freedom ac power supply cord s/n (b)(4) is starting to fray.The patient was provided with a replacement ac power supply.The freedom driver s/n (b)(4) will be returned to syncardia for evaluation.The results of the investigation will be provided in a follow-up mdr.

Manufacturer Narrative

Freedom driver s/n (b)(4) was returned to syncardia for evaluation.The onboard batteries that were used by the patient at the time of the reported fault alarm were not returned to syncardia and could not be evaluated as part of this investigation.Visual inspection of the external components revealed no abnormalities.Visual inspection of the internal components revealed foreign object debris (dust) on the exhaust fan, fan cover and speaker printed circuit board assembly (pcba).The exhaust fan functioned as intended during testing; therefore, the foreign object debris was not related to the reported fault alarm.The foreign object debris was removed during service of the driver.Review of the alarm history (eeprom) revealed no fault alarms that were recorded while the driver was in the field.Only permanent fault alarms are recorded in the alarm history.Intermittent and/or recoverable alarms, such as battery alarms, temperature alarms or fault alarms that are resolved within their corresponding recovery duration are not recorded in the alarm history.The freedom driver was tested and passed all test acceptance criteria, which included normotensive and hypertensive patient simulator settings, with no anomalies or unintended alarms.The driver was then tested for an additional 72 hours under normotensive patient simulator settings and performed as intended with no anomalies or alarms.The reported fault alarm was not reproduced.During the investigation, the freedom driver performed as intended, and there was no evidence of a device malfunction.The freedom driver was serviced and passed all final performance testing.The reported issue posed a low risk to the patient because it did not prevent the freedom driver from performing its life-sustaining functions.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.(b)(4).

Event Description

The reported issues involve the following syncardia temporary total artificial heart (tah-t) system components and are reported under three separate medical device reports: (1) primary freedom driver s/n (b)(4) (mfr report # 3003761017-2016-00129), (2) freedom ac power supply cord s/n (b)(4) (mfr report # 3003761017-2016-00130), and (3) 70cc tah-t cannula s/n (b)(4) (mfr report # 3003761017-2016-00131).On (b)(6) 2016, the customer reported that the freedom driver s/n (b)(4) exhibited a fault alarm while supporting a patient.The customer also reported that the patient was sedentary and had 2 fully charged onboard batteries in the driver during the reported event.The customer also reported that the patient was subsequently switched to the backup freedom driver.The customer also reported that there was a significant amount of air leaking out of the 70cc temporary total artificial heart (tah-t) red cannula s/n (b)(4).The customer also reported that the tear "was circular, about half of the cannula and it was about 0.5cm above the white connector." the customer also reported that the 70cc tah-t cannulae were discolored and stiff.The customer also reported that the patient applied rescue tape at home to prevent cardiac output (co) loss and another fault alarm.The customer also reported that the 70cc tah-t cannula was successfully repaired by the hospital staff when the patient was taken to the hospital.There was no reported adverse patient impact as a result of the cannula tear and subsequent repair.The customer also reported that upon the patient's arrival to the hospital, it was noted that the freedom ac power supply cord s/n (b)(4) is starting to fray.The patient was provided with a replacement ac power supply.

• 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: 5563811
• MDR Text Key: 42950295
• Report Number: 3003761017-2016-00129
• 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: 03/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2016
• 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: 04/11/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/16/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/05/2012
• 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: 49 YR