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

Catalog Number 595000-001

Device Problems Difficult to Remove (1528); Device Inoperable (1663); Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)

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

Event Date 02/18/2016

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 # 3003761017-2016-00072; freedom onboard battery s/n (b)(4) (mfr report # 3003761017-2016-00073) and freedom power adaptor s/n unknown (mfr report # 3003761017-2016-00074).The customer reported that the freedom driver s/n (b)(4) briefly stopped pumping when the hospital staff member removed the black cord on the freedom power adaptor s/n (unknown) that was connected to the driver.The hospital staff member wanted to switch the freedom power adaptor when she had difficulty removing it from freedom driver s/n (b)(4).The customer also reported that freedom driver s/n (b)(4) immediately began pumping when the freedom power adaptor black cord was reconnected.The customer also reported that the freedom driver had two fully charged onboard batteries during the reported event.The customer also reported that the freedom driver s/n (b)(4) exhibited red fault alarms when the onboard battery s/n (b)(4) was wiggled or moved in the driver.Freedom onboard battery s/n (b)(4) was on the left battery slot of the driver during the reported event.The customer also reported that the patient was subsequently switched to the backup freedom driver, freedom onboard battery and freedom power adaptor.There was no reported adverse patient impact during the reported driver stop or subsequent driver switch.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

Corrected data - power adaptor s/n changed from unknown to (b)(4).The freedom driver s/n (b)(4) was returned to syncardia for evaluation.The driver in "as received" condition passed all functional testing requirements with no anomalies or unintended alarms.The driver performed as intended, and there was no evidence of a device malfunction.Investigation of freedom power adaptor s/n (b)(4) ((mfr report # 3003761017-2016-00074) revealed no signs of damage or misuse.There was no difficulty in removing the power adaptor (s/n (b)(4)) from a freedom driver during testing.The power adaptor performed as intended, and there was no evidence of a malfunction.Investigation of freedom onboard battery s/n (b)(4) (mfr report # 3003761017-2016-00073) revealed that its output was permanently disabled by its internal safety circuitry for exhibiting cell under voltage faults.This confirms that the onboard battery was not fully charged as reported by the customer.The second freedom onboard battery used at the time of the reported event was not returned by the customer to syncardia for evaluation.Without the return of both onboard batteries for testing, a definite root cause for the reported event could not be conclusively confirmed.However, it is possible that the driver was unable to operate only on onboard battery power because of the actual state of charge of the onboard batteries or an intermittent connection between the onboard batteries and the driver; when the power adaptor was unplugged from the driver (disconnection from external a/c power source), the driver would have a complete power loss and the driver would stop.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) follow-up report 1, associated with (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 4762 (mfr report # 3003761017-2016-00072, freedom onboard battery s/n (b)(4) (mfr report # 3003761017-2016-00073) and freedom power adaptor s/n unknown (mfr report # 3003761017-2016-00074).The customer reported that the freedom driver s/n (b)(4) briefly stopped pumping when the hospital staff member removed the black cord on the freedom power adaptor s/n (b)(4) that was connected to the driver.The hospital staff member wanted to switch the freedom power adaptor when she had difficulty removing it from freedom driver s/n (b)(4).The customer also reported that freedom driver s/n (b)(4) immediately began pumping when the freedom power adaptor black cord was reconnected.The customer also reported that the freedom driver had two fully charged onboard batteries during the reported event.The customer also reported that the freedom driver s/n (b)(4) exhibited red fault alarms when the onboard battery s/n (b)(4) was wiggled or moved in the driver.Freedom onboard battery s/n (b)(4) was on the left battery slot of the driver during the reported event.The customer also reported that the patient was subsequently switched to the backup freedom driver, freedom onboard battery and freedom power adaptor.There was no reported adverse patient impact during the reported driver stop or subsequent driver switch.

• Brand Name: SYNCARDIA FREEDOM DRIVER
• Type of Device: EXTERNAL PNEUMATIC DRIVER
• Manufacturer (Section D): SYNCARDIA SYSTEMS, LLC; 1992 e. silverlake road; tucson AZ 85713
• Manufacturer Contact: michael garippa ; 1992 e. silverlake road; tucson, AZ 85713 ; 5205451234
• MDR Report Key: 5466973
• MDR Text Key: 39739262
• Report Number: 3003761017-2016-00072
• 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: 02/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/29/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 595000-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/25/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/23/2013
• 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: 55 YR