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

Catalog Number 595000-001

Device Problems No Display/Image (1183); Display or Visual Feedback Problem (1184)

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

Event Date 04/30/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4) initial.

Event Description

The customer reported that the freedom driver exhibited asterisks on the display screen instead of values for cardiac output, fill volume and beat rate, while supporting a patient at home.The customer also reported that the patient felt fine but switched to the backup freedom driver.The customer also reported that there was no adverse patient impact.This alleged failure mode poses a low risk to the patient because although the freedom driver exhibited asterisks instead of values on the display screen, 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

The freedom driver was returned to syncardia for evaluation.Visual inspection of the external components of the driver revealed physical damage that is indicative of rough handling and/or impact shock including driveline abrasions, split housings, fractured bosses and raised inserts.Visual inspection of the internal components revealed a severed red signal wire and pinched white and black wires in the air flow sensor cable.The driver passed all pressure test requirements during functional testing.The driver alarmed approximately 15 minutes following startup and showed asterisks on the driver display thus confirming the customer-reported issue.The root cause of the device malfunction which resulted in asterisks appearing on the display screen was most likely the damaged airflow sensor cable.Syncardia has an open corrective and preventative action (capa) that determined the assembly routing was causing the air flow sensor cable wires to become pinched between two internal driver components during or following driver assembly.This pinching appears to precipitate a severing of the wire.However, in this instance, it also appears that the driver was subjected to rough handling or an impact shock based on the damage found during the visual inspection.Improper use could also have contributed to the wiring damage in the air flow sensor cable.Syncardia has completed its evaluation of this complaint and is closing this file.(b)(4) follow-up report 1.

Event Description

The customer reported that the freedom driver exhibited asterisks on the display screen instead of values for cardiac output, fill volume and beat rate, while supporting a patient at home.The customer also reported that the patient felt fine but switched to the backup freedom driver.The customer also reported that there was no 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: 5642638
• MDR Text Key: 46169126
• Report Number: 3003761017-2016-00194
• 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: 04/30/2016

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: 05/05/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/30/2016
• Initial Date FDA Received: 05/09/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/02/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/07/2012
• 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: 23 YR