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

Catalog Number 595000-001

Device Problems Filling Problem (1233); Volume Accuracy Problem (1675)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/11/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(6) initial.

Event Description

On (b)(6) 2016, the customer reported that the freedom driver exhibited a fault alarm the same day the patient was given a transfusion.The customer also reported that the freedom driver exhibited intermittent fault alarms the following day.The freedom driver was exhibiting fluctuating fill volumes (fv) in the mid-30's and cardiac output (co) of 4.5-4.6 lpm (liters per minute).The patient's blood pressure was 128/50.The customer also reported that they asked the patient to report to the hospital for evaluation where the hospital staff member connected the patient to a companion 2 driver.The customer also reported that the companion 2 driver's fill volumes were in the 50's and the beat rate (br) was 130, co 7.0-7.2, and appropriate full eject flags.Due to the observed discrepancies in fill volumes from freedom driver to companion 2 driver, the customer requests the freedom driver be evaluated.This alleged failure mode poses a low risk to the patient because although the freedom driver exhibited fill volumes in the 30's, 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).

Event Description

On (b)(6) 2016, the customer reported that the freedom driver exhibited a fault alarm the same day the patient was given a transfusion.The customer also reported that the freedom driver exhibited intermittent fault alarms the following day.The freedom driver was exhibiting fluctuating fill volumes (fv) in the mid-30's and cardiac output (co) of 4.5-4.6 lpm (liters per minute).The patient's blood pressure was 128/50.The customer also reported that they asked the patient to report to the hospital for evaluation where the hospital staff member connected the patient to a companion 2 driver.The customer also reported that the companion 2 driver's fill volumes were in the 50's and the beat rate (br) was 130, co 7.0-7.2, and appropriate full eject flags.Due to the observed discrepancies in fill volumes from freedom driver to companion 2 driver, the customer requests the freedom driver be evaluated.The freedom driver was returned to syncardia for evaluation.Visual inspection of the driver's external and internal components revealed no abnormalities.Review of the alarm history electronic data confirmed that the driver did not record any permanent fault alarms related to the customer-reported issues.Intermittent, recoverable and battery alarms are not recorded in the electronic data.The driver in "as received" condition passed all test requirements with no anomalies or alarms.The driver was also subject to an additional 94 hours of continuous run-time testing and was determined to function as intended.The customer experience could not be reproduced.Therefore, the root cause of the customer-reported intermittent fault alarms and fill volume fluctuations could not be determined.Despite the customer-reported driver issues, risk to the patient was low because the driver continued to perform its life-sustaining functions.The patient was switched to a backup driver with no adverse impact.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: 5456506
• MDR Text Key: 39436076
• Report Number: 3003761017-2016-00071
• 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: 02/16/2016

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: 03/02/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/16/2016
• Initial Date FDA Received: 02/24/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/24/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/06/2015
• 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