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

Catalog Number 595000-001

Device Problems Break (1069); Device Displays Incorrect Message (2591)

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

Event Date 02/11/2016

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 two separate medical device reports: primary freedom driver s/n (b)(4) (mfr report # 3003761017-2016-00063 and backup freedom driver s/n (b)(4) (mfr report # 3003761017-2016-00064).The customer reported that the primary freedom driver s/n (b)(4) exhibited a fault alarm while the patient was switching out his onboard batteries.The customer also reported that the patient was subsequently switched to the backup freedom driver s/n (b)(4).The customer also reported that the patient noticed the power adaptor port on freedom driver s/n (b)(4) is broken.The customer also reported that the patient was subsequently switched to another backup freedom driver.There was no reported adverse patient impact.This alleged failure mode poses a low risk to the patient because although the power adaptor port is broken on freedom driver s/n (b)(4), the freedom driver continued to perform its life-sustaining functions.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

(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 # 3003761017-2016-00063 and backup freedom driver s/n (b)(4) (mfr report # 3003761017-2016-00064).The customer reported that the primary freedom driver s/n (b)(4) exhibited a fault alarm while the patient was switching out his onboard batteries.The customer also reported that the patient was subsequently switched to the backup freedom driver s/n (b)(4).The customer also reported that the patient noticed the power adaptor port on freedom driver s/n (b)(4) is broken.The customer also reported that the patient was subsequently switched to another backup freedom driver.There was no reported adverse patient impact.The freedom driver s/n (b)(4) was returned to syncardia for evaluation.Visual inspection of the exterior of the driver revealed a broken connection 1 receptacle, which connects the power adaptor to the driver, confirming the customer-reported issue.Visual inspection of the interior of the driver revealed no abnormalities.Despite the broken connection 1 receptacle, the driver in as received condition met all pressure test acceptance criteria, which included normotensive and hypertensive settings, with no anomalies or alarms.The root cause of the broken connection 1 receptacle reported by the customer and verified during visual inspection, is consistent with the result of an impact shock to the driver.Despite the customer-reported issue, risk to the patient was low because it did not prevent the driver from performing its life-sustaining functions.The freedom driver is also equipped with redundant power sources, including multiple rechargeable freedom onboard batteries and an external battery charger which provide additional means of mitigating the impact to patient care in the event that the power adapter cannot be connected.Freedom driver s/n (b)(6) was serviced.Based on days of use, the service included of the main printed circuit board assembly (pcba), speaker pcba, piston cylinder assembly (pca), and motor controller pcba, 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: 5451077
• MDR Text Key: 39208743
• Report Number: 3003761017-2016-00064
• 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: 02/11/2016

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: 02/19/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/11/2016
• Initial Date FDA Received: 02/22/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/23/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/04/2013
• 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: 59 YR