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

Catalog Number 595000-001

Device Problems No Display/Image (1183); Failure to Power Up (1476)

Patient Problems No Patient Involvement (2645); No Code Available (3191)

Event Date 03/11/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4) initial.

Event Description

The freedom driver was not supporting a patient.The customer reported that the freedom driver's display did not activate when the hospital staff member performed a system check.This alleged failure mode poses a low risk to a patient because the issue was observed when the freedom driver was not supporting a patient.In addition, it would not prevent the driver from performing 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).

Event Description

The freedom driver was not supporting a patient.The customer reported that the freedom driver's display did not activate when the hospital staff member performed a system check.The freedom driver was returned to syncardia for evaluation.Visual inspection of the driver's external components revealed no abnormalities.Visual inspection of the driver's internal components revealed that the black wire in the airflow sensor cable was severed.The black wire in the airflow sensor cable connects the flow output signal from the flow sensor to the main printed circuit board assembly (pcba).It is unknown how the black wire was severed.The electronic record did not reveal any new fault alarms when the driver last left syncardia.Only permanent fault alarms are recorded in the driver's alarm history.Intermittent, recoverable and battery alarms are not recorded in the electronic record.The driver in "as received" condition failed testing as a result of the broken black wire in the air flow sensor cable, which resulted in a fault alarm as expected.The broken wire prevented the electronics of the driver from measuring the flow sensor reading and from displaying the appropriate calculations for fill volume (fv) and cardiac output (co).Therefore, as designed, asterisks are exhibited on the display when the values are out of range.The customer reported issue was consistently seen throughout the duration of the functional testing of the driver.A fault alarm was induced at approximately 15 minutes upon startup because that is when the low cardiac output alarm is enabled.The electronics displays the asterisks as a condition in which the cardiac output is less than 3.5 liters per minute (lpm), resulting in a low cardiac output alarm and a fault code of 49 recorded in the electronic record, which occurred during investigation testing.The customer-reported issue that the display would not activate was not reproduced.However, it is likely that the customer experience was referring to the displayed asterisks, which was caused by the damaged airflow sensor cable.Despite the customer-reported display issue, risk to the patient was low because the driver was not supporting a patient at the time, and this issue would not prevent the driver from performing its life-sustaining-functions.The driver was serviced, which included the replacement of the airflow sensor cable, 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: 5517893
• MDR Text Key: 41182177
• Report Number: 3003761017-2016-00095
• 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
• Type of Report: Initial,Followup
• Report Date: 03/11/2016

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: Health Professional
• Device Catalogue Number: 595000-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/11/2016
• Initial Date FDA Received: 03/22/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/04/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/23/2011
• 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