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

Catalog Number 595000-001

Device Problems Failure to Align (2522); Device Operates Differently Than Expected (2913); Device Dislodged or Dislocated (2923)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/07/2015

Event Type  malfunction  

Event Description

The customer reported that the right driveline quick connector spring of the freedom driver was dislodged/displaced while the driver was supporting a patient.The customer also reported that the connector was attached, but not properly aligned and she had difficulty depressing the thumb release tab.The patient was subsequently switched to a companion 2 driver.There was no reported adverse patient impact.This alleged failure mode poses a low risk to the patient because although the freedom driver quick connector spring was dislodged/displaced, the freedom driver continued to perform its life-sustaining functions.While it can be difficult to depress the push button to release the quick connectors when the spring is not seated correctly, it is possible to disconnect them by using additional force.

Manufacturer Narrative

The quick connector with the dislodged/displaced spring will be returned with the freedom driver to syncardia for evaluation.The results of the investigation will be provided in a supplemental mdr.

• Brand Name: SYNCARDIA FREEDOM DRIVER
• Manufacturer (Section D): SYNCARDIA SYSTEMS, INC.; tucson AZ 85713
• Manufacturer Contact: carole marcot, esq., vp ; 1992 e. silverlake rd.; tucson, AZ 85713 ; 5205451234
• MDR Report Key: 4456051
• MDR Text Key: 5424564
• Report Number: 3003761017-2015-00346
• 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 Facility
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 01/07/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2015
• 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?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/07/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/01/2012
• 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: 37 YR