MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, LLC SYNCARDIA FREEDOM HOME AC POWER SUPPLY

Catalog Number 295600-001

Device Problems Break (1069); Crack (1135); Power Problem (3010)

Patient Problem No Patient Involvement (2645)

Event Date 11/30/2016

Event Type  malfunction  

Manufacturer Narrative

This alleged failure mode poses a low risk to the patient because was not supporting the patient at the time of event.In addition, the freedom driver has a redundant power source of onboard batteries.The freedom home ac power supply 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 freedom home ac power supply is a component that enables the freedom driver to be plugged into an external power source.The customer reported that the patient's freedom home ac power supply was broken and the cause of damage was unknown.The customer also reported that the patient was not supported by the home ac power supply at the time of the reported issue.

Manufacturer Narrative

The freedom home ac power supply was returned to syncardia for evaluation.Visual inspection of the freedom home ac power supply's exterior components revealed a broken ac cord strain relief and duct tape wrapped over a crack in the hypertronics connector cover.The broken strain relief was most likely caused by normal use of the unit over time.The root cause for the crack in the hypertronics connector is unknown.However, this type of damage to connectors has been previously investigated and was most likely caused by rough handling.It appeared that duct tape was used to repair the unit.Repair of the freedom driver or any accessories is not permitted in the approved syncardia labeling.Despite the damaged hypertronics connector, the freedom home ac power supply passed all electrical functional testing.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.(b)(4).

Event Description

The freedom home ac power supply is a component that enables the freedom driver to be plugged into an external power source.The customer reported that the patient's freedom home ac power supply was broken and the cause of damage was unknown.The customer also reported that the patient was not supported by the home ac power supply at the time of the reported issue.

• Brand Name: SYNCARDIA FREEDOM HOME AC POWER SUPPLY
• Type of Device: AC POWER SUPPLY
• 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: 6165965
• MDR Text Key: 62456123
• Report Number: 3003761017-2016-00389
• 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: 11/30/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 295600-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/19/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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: 56 YR