MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, INC. SYNCARDIA FREEDOM AC POWER SUPPLY

Catalog Number 295050-001

Device Problems Difficult to Insert (1316); Device Operational Issue (2914)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/04/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4) initial.

Event Description

The freedom ac power supply is a component that enables the freedom driver to be plugged into an external power source.The customer reported that the green connector of the freedom ac power supply was difficult to insert and does not securely connect into the freedom power adaptor.This alleged failure mode poses a low risk to the patient because it did not prevent the freedom driver from performing its life-sustaining functions.The freedom driver continued to function as intended.The freedom driver has a redundant power source of onboard batteries.The freedom ac power supply 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

The freedom ac power supply is a component that enables the freedom driver to be plugged into an external power source.The customer reported that the green connector of the freedom ac power supply was difficult to insert and did not securely connect into the freedom power adaptor.The freedom ac power supply was returned to syncardia for evaluation.Visual of the ac power supply's exterior components revealed a broken connector cover.This was identified as the likely root cause of the reported connection difficulty.The cause of the damage to the connector cover was unknown.The ac power supply was functionally tested, and despite the damage to the connector cover, it passed all functional testing.Because of the damage to the connector cover, the freedom ac power supply was taken out of service.This failure mode poses a low risk to the patient because it did not prevent the patient's freedom driver from performing its life-sustaining functions.The freedom driver continued to function as intended.In addition, the freedom driver system has redundant power sources, including an additional ac power supply, multiple rechargeable onboard batteries and a car charger.Syncardia will continue to monitor and trend this issue as part of the customer experience process.Syncardia has completed its evaluation of this complaint and is closing this file.

• Brand Name: SYNCARDIA FREEDOM AC POWER SUPPLY
• Type of Device: AC POWER SUPPLY
• 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: 5362293
• MDR Text Key: 36248256
• Report Number: 3003761017-2016-00003
• 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: 01/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 295050-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/23/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/15/2011
• 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: 43 YR