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

Catalog Number 595000-001

Device Problem Device Displays Incorrect Message (2591)

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

Event Date 09/20/2016

Event Type  malfunction  

Manufacturer Narrative

This alleged failure mode poses a low risk to the patient because although the freedom driver exhibited a fault alarm, 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.(b)(4).

Event Description

The customer reported that the freedom driver exhibited an irreversible fault alarm while the patient was lying in bed about to go to sleep.The patient's freedom driver was plugged into wall power with two fully charged onboard batteries in the battery wells.The customer also reported that the patient was normotensive at the time.The customer also reported that the patient was subsequently switched to the backup freedom driver.There was no reported adverse patient impact.

Manufacturer Narrative

The freedom driver was returned to syncardia for evaluation.The driver in "as received" condition passed all pressure test requirements, which included cardiac output, rap (right atrial pressure), aop (aortic pressure), pap (pulmonary arterial pressure) and lap (left atrial pressure) performance metrics associated with nominal normotensive and hypertensive settings.Review of the electronic data revealed a fault code of "bottom pressure too low" which is indicative of a potentially failing u22 pressure sensor on the main pcba (printed circuit board assembly) and is consistent with the alarm that the customer experienced.Further investigation of the main pcba confirmed that the root cause for the reported fault alarm was a degraded pressure sensor (u22) on the main pcba.Syncardia has initiated a corrective action (capa) to address the issue of u22 pressure sensor failures.The capa will document the investigation including, but not limited to, potential root cause and corrective actions associated with u22 pressure sensor failure events.Syncardia has completed its evaluation of this complaint and is closing this file.(b)(4).

Event Description

The customer reported that the freedom driver exhibited an irreversible fault alarm while the patient was lying in bed about to go to sleep.The patient's freedom driver was plugged into wall power with two fully charged onboard batteries in the battery wells.The customer also reported that the patient was normotensive at the time.The customer also reported that the patient was subsequently switched to the backup freedom driver.There was no reported adverse patient impact.

• 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: 6011796
• MDR Text Key: 57320445
• Report Number: 3003761017-2016-00325
• Device Sequence Number: 1
• Product Code: LOZ
• UDI-Device Identifier: 00858000003121
• UDI-Public: (01)00858000003121
• 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: 09/20/2016

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: 09/21/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/20/2016
• Initial Date FDA Received: 10/07/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/12/2011
• 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
• Patient Age: 57 YR